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[{'from': 'human', 'value': '{Study Title: A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 1467335 is Processed in the Body, Primary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Time Interval From 0 to 24 Hours After Administration of the First Dose (AUC0-24), Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose AUC 0-24.\\n\\nStandard Error presented is actually geometric Standard Error. PKS-stat including participants data for AUC(0-24). The pharmacokinetic (PK) analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was defined as primary or secondary endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability., Pharmacokinetic (PK) samples were taken 2.00 hours (h) before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Maximum Measured Concentration of BI 1467335 in Plasma After Administration of the First Dose (Cmax), Maximum measured concentration of BI 1467335 in plasma after administration of the first dose (Cmax).\\n\\nStandard Error presented is actually geometric Standard Error., Pharmacokinetic (PK) samples were taken 2.00 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 28th Dose (AUCτ,28), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 28th dose (AUCτ,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 28th Dose (Cmax,28), Maximum measured concentration of BI 1467335 in plasma following administration of the 28th dose (Cmax,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28., Secondary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 14th Dose (AUCτ,14), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 14th dose (AUCτ,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 14th Dose (Cmax,14), Maximum measured concentration of BI 1467335 in plasma following administration of the 14th dose (Cmax,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14., criteria: "Inclusion Criteria:~* Despite of moderate renal impairment (Group 1) healthy male or female subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests~* Estimated glomerular filtration rate (eGFR) based on CKD-EPI formula for Group 1 between 30 and 59 mL/min/1.73m2 and for Group 2 ≥ 90 mL/min/1.73m2~* Age of 18 to 79 years (incl.)~* BMI of 18.5 to 34 kg/m2 (incl.)~* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation~* Male subjects, or female subjects who meet any of the following criteria (according to the CTFG Recommendations related to contraception and pregnancy testing in clinical trials, methods with a failure rate of less than 1% per year) starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion, e.g.:~ * Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives (inhibition of ovulation)~ * Hormonal intrauterine device~ * Sexually abstinent (defined as refraining from heterosexual intercourse during the entire period of risk)~ * A vasectomised sexual partner (provided that vasectomy was performed at least 1 year prior to enrolment and the vasectomised partner has received medical assessment of the surgical success)~ * Surgically sterilised (including bilateral tubal occlusion, hysterectomy)~ * Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)~Exclusion Criteria:~Healthy subjects~* Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator~* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm~* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance~* Any evidence of a concomitant disease judged as clinically relevant by the investigator~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Estimated glomerular filtration rate (eGFR) calculated by CKD-EPI formula \\\\< 90 mL/min/1.73m2~Subjects with moderate renal impairment~* Subject with significant diseases other than moderate renal impairment. A significant disease is defined as a disease which in the opinion of the investigator:~ * puts the subjects at risk because of participation in the study~ * may influence the results of the study~ * may influence the subject\\s ability to participate in the study~ * is not in a stable condition Diabetic or hypertensive subjects can be entered in this trial if the disease is not significant according to these criteria.~* Any finding of the medical examination (including BP, PR and ECG) of clinical relevance~* Moderate and severe concurrent liver function impairment (e.g. due to hepatorenal syndrome) or biliary obstruction~* Clinically relevant laboratory abnormalities (except for renal function tests or deviation of clinical laboratory values that are related to renal impairment)~* eGFR calculated by CKD-EPI formula ≥ 60 mL/min/1.73m2 and \\\\< 30 mL/min/1.73m2~For all subjects~* Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)~* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders~* History of relevant orthostatic hypotension, fainting spells, or blackouts~* Chronic or relevant acute infections~* History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)~* Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)~* Participation in another trial where an investigational drug has been administered within 30 days prior to planned administration of trial medication or longer if required by local regulation, or within 5-half-lives of the investigational agent taken (whichever is longer), or current participation in another trial involving administration of investigational drug~* Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)~* Inability to refrain from smoking on specified trial days~* Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males)~* Drug abuse or positive drug screening~* Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial~* Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial~* Inability to comply with dietary regimen of trial site~* A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening~* A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)~* Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study~Female subjects will not be allowed to participate if any of the following applies:~* Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after study completion~* Lactation period~Male subjects will not be allowed to participate if any of the following applies:~- Male subjects with WOCBP partner who are unwilling to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 661, Unnamed: 0: 824, NCT Number: NCT03915340, Study Title: Bioequivalence Study of Two Formulations of Propafenone 300 mg Film-coated Tablets in Healthy Adult Volunteers After a Single Oral Dose Administration Under Fasting Conditions, Study URL: https://clinicaltrials.gov/study/NCT03915340, Acronym: , Study Status: COMPLETED, Brief Summary: This bioequivalence study will be conducted in healthy male and female volunteers in order to determine the bioequivalence of two different formulations of propafenone after a single oral dose administration under fasting conditions., Study Results: NO, Conditions: Bioequivalence, Interventions: DRUG: Propafenone|DRUG: Rytmonorm, Primary Outcome Measures: Cmax of propafenone in plasma after administration of the test and the reference products, Maximum observed concentration in plasma, Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|AUC0-T of propafenone in plasma after administration of the test and the reference products, Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration (TLQC) using the linear trapezoidal method, Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration, Secondary Outcome Measures: Tmax of propafenone in plasma after administration of the test and the reference products, Time of maximum observed concentration; if it occurs at more than one time point, Tmax is defined as the first time point with this value, Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|TLQC of propafenone in plasma after administration of the test and the reference products, Time of last observed quantifiable concentration, Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|AUC0-∞ of propafenone in plasma after administration of the test and the reference products, Area under the concentration time curve extrapolated to infinity, calculated as AUC0-T + ĈLQC (the predicted concentration at time TLQC) / λZ (apparent elimination rate constant), Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|Residual area of propafenone in plasma after administration of the test and the reference products, Extrapolated area (i.e. percentage of AUC0-∞ due to extrapolation from TLQC to infinity), Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|Time point where the log-linear elimination phase begins (TLIN) of propafenone in plasma after administration of the test and the reference products, Time point where the log-linear elimination phase begins, Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|λZ of propafenone in plasma after administration of the test and the reference products, Apparent elimination rate constant, estimated by linear regression of the terminal linear portion of the log concentration versus time curve, Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|Thalf of propafenone in plasma after administration of the test and the reference products, Terminal elimination half-life, calculated as ln(2)/λZ, Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|Number of treatment-emergent adverse events for the test and the reference products, The safety population will include all subjects who received at least one dose of the test or the reference product. Any significant changes will be recorded as treatment-emergent adverse events only if they are judged clinically significant by the qualified investigator or delegate., Up to 23 days (after the first drug administration until the completion of clinical part of the study), Other Outcome Measures: , Sponsor: Pharmtechnology LLC, Collaborators: Altasciences Company Inc., Sex: ALL, Age: ADULT, Phases: PHASE1, Enrollment: 32.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER, Other IDs: PTL-P4-227 (v. 2.0 04/09/2019), Start Date: 2019-03-23, Primary Completion Date: 2019-05-08, Completion Date: 2019-05-08, First Posted: 2019-04-16, Results First Posted: , Last Update Posted: 2019-06-06, Locations: Altasciences Company Inc., Mount-Royal, Quebec, H3P 3P1, Canada, Study Documents: , criteria: "Inclusion Criteria:~1. Provision of signed and dated informed consent form (ICF)~2. Stated willingness to comply with all study procedures and availability for the duration of the study~3. Healthy adult male or female volunteer~4. A female volunteer must meet one of the following criteria:~ 1. Participant is of childbearing potential and agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first administration of the study drug, during the study and for at least 30 days after the last dose of the study drug. An acceptable method of contraception includes one of the following:~ * Abstinence from heterosexual intercourse~ * Systemic contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch)~ * Intrauterine device (with or without hormones)~ * Condom with intra-vaginally applied spermicide~ Or~ 2. Participant whose partner has had a vasectomy less than 6 months prior to dosing, and agrees to use an additional acceptable method of contraception from the first study drug administration through to at least 30 days after the last dose of the study drug~ Or~ 3. Participant is of non-childbearing potential, defined as surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (i.e. at least 1 year without menses without an alternative medical condition prior to the first study drug administration)~5. A male volunteer meeting one of the following criteria:~ 1. Participant is able to procreate and agrees to use one of the accepted contraceptive regimens and not donate sperm from the first study drug administration to at least 90 days after the last drug administration. An acceptable method of contraception includes one of the following:~ * Abstinence from heterosexual intercourse~ * Male condom with spermicide or male condom with a vaginal spermicide (gel, foam, or suppository)~ Or~ 2. Participant is unable to procreate; defined as surgically sterile (i.e. has undergone a vasectomy at least 180 days prior to the first study drug administration)~6. Volunteer aged at least 18 years of age but not older than 45 years~7. Volunteer with a body mass index (BMI) greater than or equal to 18.50 and below 30.00 kg/m2~8. Non- or ex-smoker; an ex-smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first study drug administration~9. Clinical laboratory values within the laboratory\\s stated normal range; if not within this range, they must be without clinical significance, as determined by an investigator~10. Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or electrocardiogram (ECG), as determined by an investigator~Exclusion Criteria:~1. Females who are lactating at screening~2. Females who are pregnant according to the pregnancy test at screening or prior to the first study drug administration~3. Seated pulse rate less than 50 Beats per Minute (bpm) or more than 90 bpm at the screening visit or prior to the first study drug administration~4. History of significant hypersensitivity to propafenone or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs~5. Presence of significant gastrointestinal, liver or kidney disease, or any other condition known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects~6. History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability~7. History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease~8. Presence of out-of-range cardiac interval (PR \\\\< 110 msec, PR \\\\> 200 msec, QRS \\\\< 60 msec, QRS \\\\>110 msec and QTc \\\\> 440 msec) on the ECG at screening or other clinically significant ECG abnormalities, unless deemed non-significant by the investigator~9. History of myasthenia gravis~10. Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (\\\\> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)~11. Any clinically significant illness in the 28 days prior to the first study drug administration~12. Use of any prescription drugs (with the exception of hormonal contraceptives or hormone replacement therapy) in the 28 days prior to the first study drug administration, that in the opinion of the investigator would put into question the status of the volunteer as healthy~13. Any history of tuberculosis~14. Positive test result for alcohol and/or drugs of abuse at screening or prior to the first drug administration~15. Positive screening results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or Hepatitis C Virus (HCV (C)) tests~16. Volunteers who have already been included in a previous group for this clinical study~17. Volunteers who took propafenone in the 28 days prior to the first study drug administration~18. Volunteers who took an Investigational Product (IP) in the 28 days prior to the first study drug administration~19. Volunteers who donated 50 mL or more of blood in the 28 days prior to the first study drug administration~20. Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the 56 days prior to the first study drug administration", combined_text: Bioequivalence Study of Two Formulations of Propafenone 300 mg Film-coated Tablets in Healthy Adult Volunteers After a Single Oral Dose Administration Under Fasting Conditions Cmax of propafenone in plasma after administration of the test and the reference products, Maximum observed concentration in plasma, Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|AUC0-T of propafenone in plasma after administration of the test and the reference products, Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration (TLQC) using the linear trapezoidal method, Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration Tmax of propafenone in plasma after administration of the test and the reference products, Time of maximum observed concentration; if it occurs at more than one time point, Tmax is defined as the first time point with this value, Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|TLQC of propafenone in plasma after administration of the test and the reference products, Time of last observed quantifiable concentration, Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|AUC0-∞ of propafenone in plasma after administration of the test and the reference products, Area under the concentration time curve extrapolated to infinity, calculated as AUC0-T + ĈLQC (the predicted concentration at time TLQC) / λZ (apparent elimination rate constant), Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|Residual area of propafenone in plasma after administration of the test and the reference products, Extrapolated area (i.e. percentage of AUC0-∞ due to extrapolation from TLQC to infinity), Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|Time point where the log-linear elimination phase begins (TLIN) of propafenone in plasma after administration of the test and the reference products, Time point where the log-linear elimination phase begins, Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|λZ of propafenone in plasma after administration of the test and the reference products, Apparent elimination rate constant, estimated by linear regression of the terminal linear portion of the log concentration versus time curve, Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|Thalf of propafenone in plasma after administration of the test and the reference products, Terminal elimination half-life, calculated as ln(2)/λZ, Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|Number of treatment-emergent adverse events for the test and the reference products, The safety population will include all subjects who received at least one dose of the test or the reference product. Any significant changes will be recorded as treatment-emergent adverse events only if they are judged clinically significant by the qualified investigator or delegate., Up to 23 days (after the first drug administration until the completion of clinical part of the study) "Inclusion Criteria:~1. Provision of signed and dated informed consent form (ICF)~2. Stated willingness to comply with all study procedures and availability for the duration of the study~3. Healthy adult male or female volunteer~4. A female volunteer must meet one of the following criteria:~ 1. Participant is of childbearing potential and agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first administration of the study drug, during the study and for at least 30 days after the last dose of the study drug. An acceptable method of contraception includes one of the following:~ * Abstinence from heterosexual intercourse~ * Systemic contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch)~ * Intrauterine device (with or without hormones)~ * Condom with intra-vaginally applied spermicide~ Or~ 2. Participant whose partner has had a vasectomy less than 6 months prior to dosing, and agrees to use an additional acceptable method of contraception from the first study drug administration through to at least 30 days after the last dose of the study drug~ Or~ 3. Participant is of non-childbearing potential, defined as surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (i.e. at least 1 year without menses without an alternative medical condition prior to the first study drug administration)~5. A male volunteer meeting one of the following criteria:~ 1. Participant is able to procreate and agrees to use one of the accepted contraceptive regimens and not donate sperm from the first study drug administration to at least 90 days after the last drug administration. An acceptable method of contraception includes one of the following:~ * Abstinence from heterosexual intercourse~ * Male condom with spermicide or male condom with a vaginal spermicide (gel, foam, or suppository)~ Or~ 2. Participant is unable to procreate; defined as surgically sterile (i.e. has undergone a vasectomy at least 180 days prior to the first study drug administration)~6. Volunteer aged at least 18 years of age but not older than 45 years~7. Volunteer with a body mass index (BMI) greater than or equal to 18.50 and below 30.00 kg/m2~8. Non- or ex-smoker; an ex-smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first study drug administration~9. Clinical laboratory values within the laboratory\\s stated normal range; if not within this range, they must be without clinical significance, as determined by an investigator~10. Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or electrocardiogram (ECG), as determined by an investigator~Exclusion Criteria:~1. Females who are lactating at screening~2. Females who are pregnant according to the pregnancy test at screening or prior to the first study drug administration~3. Seated pulse rate less than 50 Beats per Minute (bpm) or more than 90 bpm at the screening visit or prior to the first study drug administration~4. History of significant hypersensitivity to propafenone or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs~5. Presence of significant gastrointestinal, liver or kidney disease, or any other condition known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects~6. History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability~7. History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease~8. Presence of out-of-range cardiac interval (PR \\\\< 110 msec, PR \\\\> 200 msec, QRS \\\\< 60 msec, QRS \\\\>110 msec and QTc \\\\> 440 msec) on the ECG at screening or other clinically significant ECG abnormalities, unless deemed non-significant by the investigator~9. History of myasthenia gravis~10. Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (\\\\> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)~11. Any clinically significant illness in the 28 days prior to the first study drug administration~12. Use of any prescription drugs (with the exception of hormonal contraceptives or hormone replacement therapy) in the 28 days prior to the first study drug administration, that in the opinion of the investigator would put into question the status of the volunteer as healthy~13. Any history of tuberculosis~14. Positive test result for alcohol and/or drugs of abuse at screening or prior to the first drug administration~15. Positive screening results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or Hepatitis C Virus (HCV (C)) tests~16. Volunteers who have already been included in a previous group for this clinical study~17. Volunteers who took propafenone in the 28 days prior to the first study drug administration~18. Volunteers who took an Investigational Product (IP) in the 28 days prior to the first study drug administration~19. Volunteers who donated 50 mL or more of blood in the 28 days prior to the first study drug administration~20. Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the 56 days prior to the first study drug administration", Similarity Score: 0.6803929794644455}'}]
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from_dataset
| 0.680393
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[{'from': 'human', 'value': '{Study Title: A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 1467335 is Processed in the Body, Primary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Time Interval From 0 to 24 Hours After Administration of the First Dose (AUC0-24), Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose AUC 0-24.\\n\\nStandard Error presented is actually geometric Standard Error. PKS-stat including participants data for AUC(0-24). The pharmacokinetic (PK) analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was defined as primary or secondary endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability., Pharmacokinetic (PK) samples were taken 2.00 hours (h) before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Maximum Measured Concentration of BI 1467335 in Plasma After Administration of the First Dose (Cmax), Maximum measured concentration of BI 1467335 in plasma after administration of the first dose (Cmax).\\n\\nStandard Error presented is actually geometric Standard Error., Pharmacokinetic (PK) samples were taken 2.00 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 28th Dose (AUCτ,28), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 28th dose (AUCτ,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 28th Dose (Cmax,28), Maximum measured concentration of BI 1467335 in plasma following administration of the 28th dose (Cmax,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28., Secondary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 14th Dose (AUCτ,14), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 14th dose (AUCτ,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 14th Dose (Cmax,14), Maximum measured concentration of BI 1467335 in plasma following administration of the 14th dose (Cmax,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14., criteria: "Inclusion Criteria:~* Despite of moderate renal impairment (Group 1) healthy male or female subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests~* Estimated glomerular filtration rate (eGFR) based on CKD-EPI formula for Group 1 between 30 and 59 mL/min/1.73m2 and for Group 2 ≥ 90 mL/min/1.73m2~* Age of 18 to 79 years (incl.)~* BMI of 18.5 to 34 kg/m2 (incl.)~* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation~* Male subjects, or female subjects who meet any of the following criteria (according to the CTFG Recommendations related to contraception and pregnancy testing in clinical trials, methods with a failure rate of less than 1% per year) starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion, e.g.:~ * Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives (inhibition of ovulation)~ * Hormonal intrauterine device~ * Sexually abstinent (defined as refraining from heterosexual intercourse during the entire period of risk)~ * A vasectomised sexual partner (provided that vasectomy was performed at least 1 year prior to enrolment and the vasectomised partner has received medical assessment of the surgical success)~ * Surgically sterilised (including bilateral tubal occlusion, hysterectomy)~ * Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)~Exclusion Criteria:~Healthy subjects~* Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator~* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm~* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance~* Any evidence of a concomitant disease judged as clinically relevant by the investigator~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Estimated glomerular filtration rate (eGFR) calculated by CKD-EPI formula \\\\< 90 mL/min/1.73m2~Subjects with moderate renal impairment~* Subject with significant diseases other than moderate renal impairment. A significant disease is defined as a disease which in the opinion of the investigator:~ * puts the subjects at risk because of participation in the study~ * may influence the results of the study~ * may influence the subject\\s ability to participate in the study~ * is not in a stable condition Diabetic or hypertensive subjects can be entered in this trial if the disease is not significant according to these criteria.~* Any finding of the medical examination (including BP, PR and ECG) of clinical relevance~* Moderate and severe concurrent liver function impairment (e.g. due to hepatorenal syndrome) or biliary obstruction~* Clinically relevant laboratory abnormalities (except for renal function tests or deviation of clinical laboratory values that are related to renal impairment)~* eGFR calculated by CKD-EPI formula ≥ 60 mL/min/1.73m2 and \\\\< 30 mL/min/1.73m2~For all subjects~* Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)~* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders~* History of relevant orthostatic hypotension, fainting spells, or blackouts~* Chronic or relevant acute infections~* History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)~* Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)~* Participation in another trial where an investigational drug has been administered within 30 days prior to planned administration of trial medication or longer if required by local regulation, or within 5-half-lives of the investigational agent taken (whichever is longer), or current participation in another trial involving administration of investigational drug~* Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)~* Inability to refrain from smoking on specified trial days~* Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males)~* Drug abuse or positive drug screening~* Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial~* Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial~* Inability to comply with dietary regimen of trial site~* A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening~* A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)~* Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study~Female subjects will not be allowed to participate if any of the following applies:~* Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after study completion~* Lactation period~Male subjects will not be allowed to participate if any of the following applies:~- Male subjects with WOCBP partner who are unwilling to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 352, Unnamed: 0: 426, NCT Number: NCT01744873, Study Title: Bioequivalence Study of Bisoprolol Fumarate Tablet 10 mg Under Fed Condition, Study URL: https://clinicaltrials.gov/study/NCT01744873, Acronym: , Study Status: COMPLETED, Brief Summary: This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fed condition in normal, healthy, adult human subjects., Study Results: NO, Conditions: Fed, Interventions: DRUG: Bisoprolol Fumarate Tablet 10 mg|DRUG: Bisoprolol, Primary Outcome Measures: Cmax, Pre-dose, 00.50, 01.00, 01.50, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 04.50, 05.00, 06.00, 07.00, 08.00, 10.00, 12.00, 16.00, 20.00, 24.00, 48.00 and 72.00 hours post-dose, 3 months|AUC, Pre-dose and at 00.50, 01.00, 01.50, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 04.50, 05.00, 06.00, 07.00, 08.00, 10.00, 12.00, 16.00, 20.00, 24.00, 48.00 and 72.00 hours post-dose., 3 months, Secondary Outcome Measures: , Other Outcome Measures: , Sponsor: IPCA Laboratories Ltd., Collaborators: , Sex: ALL, Age: ADULT, Phases: PHASE1, Enrollment: 24.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: Ipca/ARL-12/148, Start Date: 2012-08, Primary Completion Date: 2012-11, Completion Date: 2012-11, First Posted: 2012-12-07, Results First Posted: , Last Update Posted: 2012-12-07, Locations: Accutest Research Lab (I) Pvt. Ltd., Ahmedabad, Gujarat, India, Study Documents: , criteria: "Inclusion Criteria:~1. Male and Non-pregnant female human subjects, age in the range of 18 - 45 years (both inclusive).~2. Body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart.~3. Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and oral temperature).~4. Subjects with clinically acceptable findings as determined by haemogram, biochemistry, serology (HIV, Hepatitis B and Hepatitis C), urinalysis, 12 lead ECG and chest X-ray (chest X-ray if required).~5. Willingness to follow the protocol requirements as evidenced by written informed consent.~6. Subject willing to give written informed consent.~7. Confirming and agreeing to, not using any prescription and over the counter medications including vitamins and minerals for 14 days prior to study and during the course of the study.~8. No history of drug abuse in the past one year.~9. Non-smokers and non-alcoholics.~For female subject~* was child bearing potential practicing acceptable method of birth control for the duration of the study as judged by Investigator such as Condom, Foams, Jellies, Diaphragm, Intrauterine device and Abstinence.~OR~* was surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the subject).~Exclusion Criteria:~1. Known history of hypersensitivity to Bisoprolol Fumarate, or related drugs.~2. Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.~3. Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.~4. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases and bleeding tendency.~5. Participation in a clinical drug study or bioequivalence study within 90 days prior to present study.~6. History of malignancy or other serious diseases.~7. Refusal to abstain from food for at least 10.00 hours prior to receiving the high-fat and high-calorie breakfast and for at least 04.00 hours post-dose, in each study period.~8. Any contraindication to blood sampling or difficulty in accessibility of veins.~9. Refusal to abstain from fluid for at least 01.00 hour prior to study drug administration and for at least 01.00 additional hour post-dose, in each study period except about 240 mL of water given during administration of study drug.~10. Refusal to avoid the use of xanthine-containing food or beverages (chocolates, tea, coffee or cola drinks) or fruit juice/grapefruit juice and any alcoholic products for 48.00 hours prior to dosing until the last blood sample collection of last study period.~11. Blood donation within 90 days prior to the commencement of the study.~12. Subjects with positive HIV tests or Hepatitis-B or Hepatitis-C tests.~13. Found positive in breath alcohol test done before check-in for each study period.~14. Found positive in urine test for drugs of abuse done before check-in for each study period.~15. Refusal to abstain from consumption of tobacco products 24.00 hours prior to dosing until the last blood sample collection of last study period.~16. History of problem in swallowing Tablet(s).~17. Female subject, demonstrating positive urine pregnancy test at the time of screening.~18. Female subject, demonstrating positive Serum (ß) Beta- hCG (Human Chorionic Gonadotropin) test before check-in for each study period.~19. Female subject, currently breast feeding or lactating.~20. Female subjects not willing to use acceptable method of contraception from the date of screening until the completion of the study.", combined_text: Bioequivalence Study of Bisoprolol Fumarate Tablet 10 mg Under Fed Condition Cmax, Pre-dose, 00.50, 01.00, 01.50, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 04.50, 05.00, 06.00, 07.00, 08.00, 10.00, 12.00, 16.00, 20.00, 24.00, 48.00 and 72.00 hours post-dose, 3 months|AUC, Pre-dose and at 00.50, 01.00, 01.50, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 04.50, 05.00, 06.00, 07.00, 08.00, 10.00, 12.00, 16.00, 20.00, 24.00, 48.00 and 72.00 hours post-dose., 3 months "Inclusion Criteria:~1. Male and Non-pregnant female human subjects, age in the range of 18 - 45 years (both inclusive).~2. Body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart.~3. Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and oral temperature).~4. Subjects with clinically acceptable findings as determined by haemogram, biochemistry, serology (HIV, Hepatitis B and Hepatitis C), urinalysis, 12 lead ECG and chest X-ray (chest X-ray if required).~5. Willingness to follow the protocol requirements as evidenced by written informed consent.~6. Subject willing to give written informed consent.~7. Confirming and agreeing to, not using any prescription and over the counter medications including vitamins and minerals for 14 days prior to study and during the course of the study.~8. No history of drug abuse in the past one year.~9. Non-smokers and non-alcoholics.~For female subject~* was child bearing potential practicing acceptable method of birth control for the duration of the study as judged by Investigator such as Condom, Foams, Jellies, Diaphragm, Intrauterine device and Abstinence.~OR~* was surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the subject).~Exclusion Criteria:~1. Known history of hypersensitivity to Bisoprolol Fumarate, or related drugs.~2. Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.~3. Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.~4. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases and bleeding tendency.~5. Participation in a clinical drug study or bioequivalence study within 90 days prior to present study.~6. History of malignancy or other serious diseases.~7. Refusal to abstain from food for at least 10.00 hours prior to receiving the high-fat and high-calorie breakfast and for at least 04.00 hours post-dose, in each study period.~8. Any contraindication to blood sampling or difficulty in accessibility of veins.~9. Refusal to abstain from fluid for at least 01.00 hour prior to study drug administration and for at least 01.00 additional hour post-dose, in each study period except about 240 mL of water given during administration of study drug.~10. Refusal to avoid the use of xanthine-containing food or beverages (chocolates, tea, coffee or cola drinks) or fruit juice/grapefruit juice and any alcoholic products for 48.00 hours prior to dosing until the last blood sample collection of last study period.~11. Blood donation within 90 days prior to the commencement of the study.~12. Subjects with positive HIV tests or Hepatitis-B or Hepatitis-C tests.~13. Found positive in breath alcohol test done before check-in for each study period.~14. Found positive in urine test for drugs of abuse done before check-in for each study period.~15. Refusal to abstain from consumption of tobacco products 24.00 hours prior to dosing until the last blood sample collection of last study period.~16. History of problem in swallowing Tablet(s).~17. Female subject, demonstrating positive urine pregnancy test at the time of screening.~18. Female subject, demonstrating positive Serum (ß) Beta- hCG (Human Chorionic Gonadotropin) test before check-in for each study period.~19. Female subject, currently breast feeding or lactating.~20. Female subjects not willing to use acceptable method of contraception from the date of screening until the completion of the study.", Similarity Score: 0.672497819310299}'}]
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from_dataset
| 0.672498
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[{'from': 'human', 'value': '{Study Title: A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 1467335 is Processed in the Body, Primary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Time Interval From 0 to 24 Hours After Administration of the First Dose (AUC0-24), Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose AUC 0-24.\\n\\nStandard Error presented is actually geometric Standard Error. PKS-stat including participants data for AUC(0-24). The pharmacokinetic (PK) analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was defined as primary or secondary endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability., Pharmacokinetic (PK) samples were taken 2.00 hours (h) before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Maximum Measured Concentration of BI 1467335 in Plasma After Administration of the First Dose (Cmax), Maximum measured concentration of BI 1467335 in plasma after administration of the first dose (Cmax).\\n\\nStandard Error presented is actually geometric Standard Error., Pharmacokinetic (PK) samples were taken 2.00 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 28th Dose (AUCτ,28), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 28th dose (AUCτ,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 28th Dose (Cmax,28), Maximum measured concentration of BI 1467335 in plasma following administration of the 28th dose (Cmax,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28., Secondary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 14th Dose (AUCτ,14), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 14th dose (AUCτ,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 14th Dose (Cmax,14), Maximum measured concentration of BI 1467335 in plasma following administration of the 14th dose (Cmax,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14., criteria: "Inclusion Criteria:~* Despite of moderate renal impairment (Group 1) healthy male or female subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests~* Estimated glomerular filtration rate (eGFR) based on CKD-EPI formula for Group 1 between 30 and 59 mL/min/1.73m2 and for Group 2 ≥ 90 mL/min/1.73m2~* Age of 18 to 79 years (incl.)~* BMI of 18.5 to 34 kg/m2 (incl.)~* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation~* Male subjects, or female subjects who meet any of the following criteria (according to the CTFG Recommendations related to contraception and pregnancy testing in clinical trials, methods with a failure rate of less than 1% per year) starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion, e.g.:~ * Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives (inhibition of ovulation)~ * Hormonal intrauterine device~ * Sexually abstinent (defined as refraining from heterosexual intercourse during the entire period of risk)~ * A vasectomised sexual partner (provided that vasectomy was performed at least 1 year prior to enrolment and the vasectomised partner has received medical assessment of the surgical success)~ * Surgically sterilised (including bilateral tubal occlusion, hysterectomy)~ * Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)~Exclusion Criteria:~Healthy subjects~* Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator~* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm~* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance~* Any evidence of a concomitant disease judged as clinically relevant by the investigator~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Estimated glomerular filtration rate (eGFR) calculated by CKD-EPI formula \\\\< 90 mL/min/1.73m2~Subjects with moderate renal impairment~* Subject with significant diseases other than moderate renal impairment. A significant disease is defined as a disease which in the opinion of the investigator:~ * puts the subjects at risk because of participation in the study~ * may influence the results of the study~ * may influence the subject\\s ability to participate in the study~ * is not in a stable condition Diabetic or hypertensive subjects can be entered in this trial if the disease is not significant according to these criteria.~* Any finding of the medical examination (including BP, PR and ECG) of clinical relevance~* Moderate and severe concurrent liver function impairment (e.g. due to hepatorenal syndrome) or biliary obstruction~* Clinically relevant laboratory abnormalities (except for renal function tests or deviation of clinical laboratory values that are related to renal impairment)~* eGFR calculated by CKD-EPI formula ≥ 60 mL/min/1.73m2 and \\\\< 30 mL/min/1.73m2~For all subjects~* Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)~* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders~* History of relevant orthostatic hypotension, fainting spells, or blackouts~* Chronic or relevant acute infections~* History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)~* Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)~* Participation in another trial where an investigational drug has been administered within 30 days prior to planned administration of trial medication or longer if required by local regulation, or within 5-half-lives of the investigational agent taken (whichever is longer), or current participation in another trial involving administration of investigational drug~* Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)~* Inability to refrain from smoking on specified trial days~* Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males)~* Drug abuse or positive drug screening~* Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial~* Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial~* Inability to comply with dietary regimen of trial site~* A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening~* A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)~* Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study~Female subjects will not be allowed to participate if any of the following applies:~* Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after study completion~* Lactation period~Male subjects will not be allowed to participate if any of the following applies:~- Male subjects with WOCBP partner who are unwilling to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 738, Unnamed: 0: 924, NCT Number: NCT01513044, Study Title: Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule, Under Fasting Conditions, Study URL: https://clinicaltrials.gov/study/NCT01513044, Acronym: , Study Status: COMPLETED, Brief Summary: "An open-label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, bioequivalence study of Mycophenolate mofetil 250 mg Capsule of Dr. Reddys Laboratories limited, comparing with that of Cellcept 250 mg Capsule of Roche Laboratories in healthy, adult,human, male subjects under fasting conditions.", Study Results: NO, Conditions: Healthy, Interventions: DRUG: Mycophenolate Mofetil|DRUG: Mycophenolate Mofetil, Primary Outcome Measures: Area Under Curve (AUC), Pre-dose, 0.083, 0.167, 0.25, 0.333, 0.41, 0.50, 0.667, 0.833, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 60.00 and 72.00 post dose, Secondary Outcome Measures: , Other Outcome Measures: , Sponsor: "Dr. Reddys Laboratories Limited", Collaborators: , Sex: ALL, Age: ADULT, Phases: PHASE1, Enrollment: 68.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: 08-VIN-182, Start Date: 2009-01, Primary Completion Date: 2009-01, Completion Date: 2009-01, First Posted: 2012-01-20, Results First Posted: , Last Update Posted: 2012-01-20, Locations: veeda clinical research Pvt. Ltd, Ahmedabad, Gujarat, 3 80 015, India, Study Documents: , criteria: "Inclusion Criteria:~* Subjects aged between 18 and 50 years (including both).~* Subjects\\ weight within the normal range according to normal values for the Body~* Mass Index (1 8.5 to 24.9 kg/m2) with minimum of 50 kg weight.~* Subjects with clinically acceptable normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable reference range.~* Subjects having clinically acceptable 12-lead electrocardiogram (ECG).~* Subjects having clinically acceptable chest X-Ray (PIA view).~* Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).~* Subjects having negative alcohol breath test.~* Subjects willing to adhere to the protocol requirements and to provide written informed consent.~Exclusion Criteria:~The subjects were excluded from the study, if they meet any of the following criteria:~* Hypersensitivity to Mycophenolate Mofetil or related drugs.~* History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.~* History or presence of significant alcoholism or drug abuse in the past one year.~* History or presence of significant smoking (more than 10 cigarettes day or consumption of tobacco products).~* History or presence of asthma, urticaria or other significant allergic reactions.~* History or presence of significant gastric and/or duodenal ulceration.~* History or presence of glaucoma, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm and myasthenia gravis.~* History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.~* History or presence of cancer.~* Difficulty with donating blood.~* Difficulty in swallowing solids like tablets or capsules.~* Use of any prescribed medication or OTC medicinal products during the last two week prior to initiation of study.~* Major illness during 3 months before screening.~* Participation in a drug research study within past 3 months.~* Donation of blood in the past 3 months before screening.~* Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.~* History or presence of significant easy bruising or bleeding.~* History or presence of significant recent trauma.", combined_text: Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule, Under Fasting Conditions Area Under Curve (AUC), Pre-dose, 0.083, 0.167, 0.25, 0.333, 0.41, 0.50, 0.667, 0.833, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 60.00 and 72.00 post dose "Inclusion Criteria:~* Subjects aged between 18 and 50 years (including both).~* Subjects\\ weight within the normal range according to normal values for the Body~* Mass Index (1 8.5 to 24.9 kg/m2) with minimum of 50 kg weight.~* Subjects with clinically acceptable normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable reference range.~* Subjects having clinically acceptable 12-lead electrocardiogram (ECG).~* Subjects having clinically acceptable chest X-Ray (PIA view).~* Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).~* Subjects having negative alcohol breath test.~* Subjects willing to adhere to the protocol requirements and to provide written informed consent.~Exclusion Criteria:~The subjects were excluded from the study, if they meet any of the following criteria:~* Hypersensitivity to Mycophenolate Mofetil or related drugs.~* History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.~* History or presence of significant alcoholism or drug abuse in the past one year.~* History or presence of significant smoking (more than 10 cigarettes day or consumption of tobacco products).~* History or presence of asthma, urticaria or other significant allergic reactions.~* History or presence of significant gastric and/or duodenal ulceration.~* History or presence of glaucoma, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm and myasthenia gravis.~* History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.~* History or presence of cancer.~* Difficulty with donating blood.~* Difficulty in swallowing solids like tablets or capsules.~* Use of any prescribed medication or OTC medicinal products during the last two week prior to initiation of study.~* Major illness during 3 months before screening.~* Participation in a drug research study within past 3 months.~* Donation of blood in the past 3 months before screening.~* Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.~* History or presence of significant easy bruising or bleeding.~* History or presence of significant recent trauma.", Similarity Score: 0.6069201503187602}'}]
|
from_dataset
| 0.60692
|
[{'from': 'human', 'value': '{Study Title: A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 1467335 is Processed in the Body, Primary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Time Interval From 0 to 24 Hours After Administration of the First Dose (AUC0-24), Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose AUC 0-24.\\n\\nStandard Error presented is actually geometric Standard Error. PKS-stat including participants data for AUC(0-24). The pharmacokinetic (PK) analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was defined as primary or secondary endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability., Pharmacokinetic (PK) samples were taken 2.00 hours (h) before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Maximum Measured Concentration of BI 1467335 in Plasma After Administration of the First Dose (Cmax), Maximum measured concentration of BI 1467335 in plasma after administration of the first dose (Cmax).\\n\\nStandard Error presented is actually geometric Standard Error., Pharmacokinetic (PK) samples were taken 2.00 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 28th Dose (AUCτ,28), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 28th dose (AUCτ,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 28th Dose (Cmax,28), Maximum measured concentration of BI 1467335 in plasma following administration of the 28th dose (Cmax,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28., Secondary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 14th Dose (AUCτ,14), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 14th dose (AUCτ,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 14th Dose (Cmax,14), Maximum measured concentration of BI 1467335 in plasma following administration of the 14th dose (Cmax,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14., criteria: "Inclusion Criteria:~* Despite of moderate renal impairment (Group 1) healthy male or female subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests~* Estimated glomerular filtration rate (eGFR) based on CKD-EPI formula for Group 1 between 30 and 59 mL/min/1.73m2 and for Group 2 ≥ 90 mL/min/1.73m2~* Age of 18 to 79 years (incl.)~* BMI of 18.5 to 34 kg/m2 (incl.)~* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation~* Male subjects, or female subjects who meet any of the following criteria (according to the CTFG Recommendations related to contraception and pregnancy testing in clinical trials, methods with a failure rate of less than 1% per year) starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion, e.g.:~ * Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives (inhibition of ovulation)~ * Hormonal intrauterine device~ * Sexually abstinent (defined as refraining from heterosexual intercourse during the entire period of risk)~ * A vasectomised sexual partner (provided that vasectomy was performed at least 1 year prior to enrolment and the vasectomised partner has received medical assessment of the surgical success)~ * Surgically sterilised (including bilateral tubal occlusion, hysterectomy)~ * Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)~Exclusion Criteria:~Healthy subjects~* Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator~* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm~* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance~* Any evidence of a concomitant disease judged as clinically relevant by the investigator~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Estimated glomerular filtration rate (eGFR) calculated by CKD-EPI formula \\\\< 90 mL/min/1.73m2~Subjects with moderate renal impairment~* Subject with significant diseases other than moderate renal impairment. A significant disease is defined as a disease which in the opinion of the investigator:~ * puts the subjects at risk because of participation in the study~ * may influence the results of the study~ * may influence the subject\\s ability to participate in the study~ * is not in a stable condition Diabetic or hypertensive subjects can be entered in this trial if the disease is not significant according to these criteria.~* Any finding of the medical examination (including BP, PR and ECG) of clinical relevance~* Moderate and severe concurrent liver function impairment (e.g. due to hepatorenal syndrome) or biliary obstruction~* Clinically relevant laboratory abnormalities (except for renal function tests or deviation of clinical laboratory values that are related to renal impairment)~* eGFR calculated by CKD-EPI formula ≥ 60 mL/min/1.73m2 and \\\\< 30 mL/min/1.73m2~For all subjects~* Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)~* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders~* History of relevant orthostatic hypotension, fainting spells, or blackouts~* Chronic or relevant acute infections~* History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)~* Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)~* Participation in another trial where an investigational drug has been administered within 30 days prior to planned administration of trial medication or longer if required by local regulation, or within 5-half-lives of the investigational agent taken (whichever is longer), or current participation in another trial involving administration of investigational drug~* Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)~* Inability to refrain from smoking on specified trial days~* Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males)~* Drug abuse or positive drug screening~* Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial~* Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial~* Inability to comply with dietary regimen of trial site~* A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening~* A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)~* Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study~Female subjects will not be allowed to participate if any of the following applies:~* Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after study completion~* Lactation period~Male subjects will not be allowed to participate if any of the following applies:~- Male subjects with WOCBP partner who are unwilling to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 871, Unnamed: 0: 1092, NCT Number: NCT00460473, Study Title: A Research Study to Evaluate the Effectiveness of Dexmedetomidine in Preventing Delirium After Hip Fracture Repair Surgery, Study URL: https://clinicaltrials.gov/study/NCT00460473, Acronym: , Study Status: TERMINATED, Brief Summary: The purpose of this study is to evaluate the efficacy and safety of perioperative use of dexmedetomidine in the prevention of postoperative delirium in subjects undergoing surgery for fractured hip with general anesthesia., Study Results: NO, Conditions: Delirium, Interventions: DRUG: Dexmedetomidine|DRUG: Placebo, Primary Outcome Measures: Percentage of subjects who experienced any postoperative delirium up to 3 days after the end of study drug infusion, The presence of postoperative delirium will be determined by Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)., Twice daily (between 6:00-9:00 AM and 5:00-8:00 PM) until 3 days after the end of study drug infusion., Secondary Outcome Measures: Duration of postoperative delirium as determined by CAM-ICU up to 3 days after end of study drug infusion, Twice daily (between 6:00-9:00 AM and 5:00-8:00 PM) until 3 days after the end of study drug infusion.|Percentage of subjects who experienced postoperative delirium each day after end of study drug infusion, Twice daily (between 6:00-9:00 AM and 5:00-8:00 PM) until 3 days after the end of study drug infusion.|Perioperative use of all analgesics (Fentanyl, Morphine, and oral analgesics), During the intraoperative period, Post-anesthesia care unit period and the 3 days Follow-up Period.|Postoperative use of Midazolam, If RASS \\\\>0, midazolam (MDZ) 0.5-1 mg IV will be given until RASS \\\\<0. While in PACU during study drug infusion period, MDZ (0.5-1 mg IV) will be given if RASS \\\\>+1 under allowed maximum dose of study drug.\\n\\nRASS range:\\n\\n* +4 Combative -Overtly combative, violent, immediate danger to staff\\n* +3 Very agitated- Pulls or removes tubes or catheters, aggressive\\n* +2 Agitated- Frequent non-purposeful movements, fights ventilator\\n* +1 Restless- Anxious, but movements not aggressive or vigorous\\n* 0 Alert and calm\\n* -1 Drowsy - Not fully alert, but sustained awakening (eye opening, eye contact) to voice (\\\\>10 sec)\\n* -2 Light sedation - Briefly awakens with eye contact to voice (\\\\<10 sec)\\n* -3 Moderate sedation - Movement or eye opening to voice (but no eye contact)\\n* -4 Deep sedation No response to voice, but movement or eye opening to physical stimulation\\n* -5 Unarousable No response to voice or physical stimulation, During the PACU period (Approximately 2 hours)|Time-to-Aldrete score of ≥9, A score of 9-10 indicates the subject has recovered from anesthesia and is ready for discharge from the PACU., Every 15±5 minutes from arrival in the PACU (Approximately 2 hours)|Length of post-operative hospital stay, From the post operative period until subject discharged from hospital, Other Outcome Measures: , Sponsor: Hospira, now a wholly owned subsidiary of Pfizer, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE3, Enrollment: 52.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION, Other IDs: DEX-06-09, Start Date: 2007-04, Primary Completion Date: 2007-11, Completion Date: 2007-11, First Posted: 2007-04-16, Results First Posted: , Last Update Posted: 2015-07-24, Locations: "Loma Linda University Medical Center, Loma Linda, California, 92354, United States|LAC-USC Medical Center Los Angeles, Los Angeles, California, 90033, United States|Huntington Memorial Hospital, Pasadena, California, 91105, United States|University of Miami-Jackson Memorial Medical Center, Miami, Florida, 33101, United States|Southeastern Clinical Research Consultants, Orlando, Florida, 32804, United States|Orlando Regional Healthcare, Critical Care Medicine, Orlando, Florida, 32806, United States|G and G Research, Inc., Vero Beach, Florida, 32960, United States|Orthopaedic Center of Vero Beach, Vero Beach, Florida, 32960, United States|Medical College of Georgia, Augusta, Georgia, 30912, United States|University of Iowa Hospitals and Clinics, Dept. of Anesthesia, Iowa City, Iowa, 52242-1053, United States|Outcomes Research Institute, Louisville, Kentucky, 40202, United States|Louisiana State University, Dept. of Orthopaedic Surgery, Shreveport, Louisiana, 71103, United States|Spectrum Health Blodgett Campus, Grand Rapids, Michigan, 49506-2810, United States|William Beaumont Hospital, Royal Oak, Michigan, 48073, United States|Saint Marys Duluth Clinic Health System, Duluth, Minnesota, 55805, United States|Mayo Clinic College of Medicine, Dept. of Anesthesiology, Rochester, Minnesota, 55906, United States|University of Missouri, Columbia, Missouri, 65212, United States|Mount Sinai School of Medicine, Great Neck, New York, 11021, United States|New York University Medical Center, New York, New York, 10016, United States|Duke University Medical Center, Durham, North Carolina, 27705, United States|The Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States|Ohio State University Medical Center, Columbus, Ohio, 43210, United States|University of Pittsburgh Medical Center, Presbyterian, Pittsburgh, Pennsylvania, 15213-2582, United States|University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, 15232, United States|Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States|Research Concepts, Bellaire, Texas, 77401, United States|Parkland Health and Hospital System, Dallas, Texas, 75390-9179, United States|University of Virginia Health Systems, Charlottesville, Virginia, 22908-0710, United States|University of Wisconsin Medical School, Dept. of Anesthesiology, Madison, Wisconsin, 53792, United States|VA Medical Center, Milwaukee, Wisconsin, 53295, United States", Study Documents: , criteria: "Inclusion Criteria:~1. Adult (≥18 years old) male or female who will undergo surgery for fractured hip with general anesthesia within 72 hours of admission to hospital.~2. If female, subject is non-lactating and is either:~ 1. Not of childbearing potential, defined as post-menopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy or hysterectomy.~ 2. Of childbearing potential but is not pregnant at time of baseline and is practicing one of the following methods of birth control: oral or parenteral contraceptives, double-barrier method, vasectomized partner, or abstinence from sexual intercourse.~3. Subject is American Society of Anesthesiologists Physical Status I, II, III, or IV.~4. Subject (or subject\\s legally authorized representative) has voluntarily signed and dated the informed consent document approved by the Institutional Review Board (IRB).~Exclusion Criteria:~1. Cognitive function level by Mini Mental State Exam (MMSE) of ≤20.~2. Subject has a positive CAM-ICU result for delirium at Screening or Baseline.~3. Subject requires chronic antipsychotic therapy.~4. Subject is anticipated to require additional surgical procedures during the 72 hour Screening Period and the 3 days Follow-up Period.~5. Subject is anticipated to require repair of pelvic fractures (eg,acetabulum).~6. Subject has participated in a trial with any experimental drug or experimental implantable device within 30 days prior to the study drug administration, or has ever been enrolled in this study.~7. Subject known to be in liver failure.~8. Subject has an anticipated potential for increased intracranial pressure or an uncontrolled seizure disorder or known psychiatric illness that could confound a normal response during study assessment.~9. Subject has received treatment with a α2-agonist or antagonist (within 14 days of study entry).~10. Subject for whom opiates, benzodiazepines, DEX or other α2-agonists are contraindicated.~11. Subject has, per the investigator\\s judgment, a known or suspected physical or psychological dependence on an abused drug, other than alcohol.~12. Subject has acute unstable angina, acute myocardial infarction, HR \\\\<50 bpm, SBP \\\\<90 mmHg, or third degree heart block unless the subject has a pacemaker.~13. Subject has any condition or factor which, in the Investigator\\s opinion, might increase the risk to the subject.~14. Subject is not expected to live more than 60 days.", combined_text: A Research Study to Evaluate the Effectiveness of Dexmedetomidine in Preventing Delirium After Hip Fracture Repair Surgery Percentage of subjects who experienced any postoperative delirium up to 3 days after the end of study drug infusion, The presence of postoperative delirium will be determined by Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)., Twice daily (between 6:00-9:00 AM and 5:00-8:00 PM) until 3 days after the end of study drug infusion. Duration of postoperative delirium as determined by CAM-ICU up to 3 days after end of study drug infusion, Twice daily (between 6:00-9:00 AM and 5:00-8:00 PM) until 3 days after the end of study drug infusion.|Percentage of subjects who experienced postoperative delirium each day after end of study drug infusion, Twice daily (between 6:00-9:00 AM and 5:00-8:00 PM) until 3 days after the end of study drug infusion.|Perioperative use of all analgesics (Fentanyl, Morphine, and oral analgesics), During the intraoperative period, Post-anesthesia care unit period and the 3 days Follow-up Period.|Postoperative use of Midazolam, If RASS \\\\>0, midazolam (MDZ) 0.5-1 mg IV will be given until RASS \\\\<0. While in PACU during study drug infusion period, MDZ (0.5-1 mg IV) will be given if RASS \\\\>+1 under allowed maximum dose of study drug.\\n\\nRASS range:\\n\\n* +4 Combative -Overtly combative, violent, immediate danger to staff\\n* +3 Very agitated- Pulls or removes tubes or catheters, aggressive\\n* +2 Agitated- Frequent non-purposeful movements, fights ventilator\\n* +1 Restless- Anxious, but movements not aggressive or vigorous\\n* 0 Alert and calm\\n* -1 Drowsy - Not fully alert, but sustained awakening (eye opening, eye contact) to voice (\\\\>10 sec)\\n* -2 Light sedation - Briefly awakens with eye contact to voice (\\\\<10 sec)\\n* -3 Moderate sedation - Movement or eye opening to voice (but no eye contact)\\n* -4 Deep sedation No response to voice, but movement or eye opening to physical stimulation\\n* -5 Unarousable No response to voice or physical stimulation, During the PACU period (Approximately 2 hours)|Time-to-Aldrete score of ≥9, A score of 9-10 indicates the subject has recovered from anesthesia and is ready for discharge from the PACU., Every 15±5 minutes from arrival in the PACU (Approximately 2 hours)|Length of post-operative hospital stay, From the post operative period until subject discharged from hospital "Inclusion Criteria:~1. Adult (≥18 years old) male or female who will undergo surgery for fractured hip with general anesthesia within 72 hours of admission to hospital.~2. If female, subject is non-lactating and is either:~ 1. Not of childbearing potential, defined as post-menopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy or hysterectomy.~ 2. Of childbearing potential but is not pregnant at time of baseline and is practicing one of the following methods of birth control: oral or parenteral contraceptives, double-barrier method, vasectomized partner, or abstinence from sexual intercourse.~3. Subject is American Society of Anesthesiologists Physical Status I, II, III, or IV.~4. Subject (or subject\\s legally authorized representative) has voluntarily signed and dated the informed consent document approved by the Institutional Review Board (IRB).~Exclusion Criteria:~1. Cognitive function level by Mini Mental State Exam (MMSE) of ≤20.~2. Subject has a positive CAM-ICU result for delirium at Screening or Baseline.~3. Subject requires chronic antipsychotic therapy.~4. Subject is anticipated to require additional surgical procedures during the 72 hour Screening Period and the 3 days Follow-up Period.~5. Subject is anticipated to require repair of pelvic fractures (eg,acetabulum).~6. Subject has participated in a trial with any experimental drug or experimental implantable device within 30 days prior to the study drug administration, or has ever been enrolled in this study.~7. Subject known to be in liver failure.~8. Subject has an anticipated potential for increased intracranial pressure or an uncontrolled seizure disorder or known psychiatric illness that could confound a normal response during study assessment.~9. Subject has received treatment with a α2-agonist or antagonist (within 14 days of study entry).~10. Subject for whom opiates, benzodiazepines, DEX or other α2-agonists are contraindicated.~11. Subject has, per the investigator\\s judgment, a known or suspected physical or psychological dependence on an abused drug, other than alcohol.~12. Subject has acute unstable angina, acute myocardial infarction, HR \\\\<50 bpm, SBP \\\\<90 mmHg, or third degree heart block unless the subject has a pacemaker.~13. Subject has any condition or factor which, in the Investigator\\s opinion, might increase the risk to the subject.~14. Subject is not expected to live more than 60 days.", Similarity Score: 0.3264345263251206}'}]
|
from_dataset
| 0.326435
|
[{'from': 'human', 'value': '{Study Title: A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 1467335 is Processed in the Body, Primary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Time Interval From 0 to 24 Hours After Administration of the First Dose (AUC0-24), Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose AUC 0-24.\\n\\nStandard Error presented is actually geometric Standard Error. PKS-stat including participants data for AUC(0-24). The pharmacokinetic (PK) analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was defined as primary or secondary endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability., Pharmacokinetic (PK) samples were taken 2.00 hours (h) before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Maximum Measured Concentration of BI 1467335 in Plasma After Administration of the First Dose (Cmax), Maximum measured concentration of BI 1467335 in plasma after administration of the first dose (Cmax).\\n\\nStandard Error presented is actually geometric Standard Error., Pharmacokinetic (PK) samples were taken 2.00 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 28th Dose (AUCτ,28), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 28th dose (AUCτ,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 28th Dose (Cmax,28), Maximum measured concentration of BI 1467335 in plasma following administration of the 28th dose (Cmax,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28., Secondary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 14th Dose (AUCτ,14), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 14th dose (AUCτ,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 14th Dose (Cmax,14), Maximum measured concentration of BI 1467335 in plasma following administration of the 14th dose (Cmax,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14., criteria: "Inclusion Criteria:~* Despite of moderate renal impairment (Group 1) healthy male or female subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests~* Estimated glomerular filtration rate (eGFR) based on CKD-EPI formula for Group 1 between 30 and 59 mL/min/1.73m2 and for Group 2 ≥ 90 mL/min/1.73m2~* Age of 18 to 79 years (incl.)~* BMI of 18.5 to 34 kg/m2 (incl.)~* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation~* Male subjects, or female subjects who meet any of the following criteria (according to the CTFG Recommendations related to contraception and pregnancy testing in clinical trials, methods with a failure rate of less than 1% per year) starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion, e.g.:~ * Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives (inhibition of ovulation)~ * Hormonal intrauterine device~ * Sexually abstinent (defined as refraining from heterosexual intercourse during the entire period of risk)~ * A vasectomised sexual partner (provided that vasectomy was performed at least 1 year prior to enrolment and the vasectomised partner has received medical assessment of the surgical success)~ * Surgically sterilised (including bilateral tubal occlusion, hysterectomy)~ * Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)~Exclusion Criteria:~Healthy subjects~* Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator~* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm~* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance~* Any evidence of a concomitant disease judged as clinically relevant by the investigator~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Estimated glomerular filtration rate (eGFR) calculated by CKD-EPI formula \\\\< 90 mL/min/1.73m2~Subjects with moderate renal impairment~* Subject with significant diseases other than moderate renal impairment. A significant disease is defined as a disease which in the opinion of the investigator:~ * puts the subjects at risk because of participation in the study~ * may influence the results of the study~ * may influence the subject\\s ability to participate in the study~ * is not in a stable condition Diabetic or hypertensive subjects can be entered in this trial if the disease is not significant according to these criteria.~* Any finding of the medical examination (including BP, PR and ECG) of clinical relevance~* Moderate and severe concurrent liver function impairment (e.g. due to hepatorenal syndrome) or biliary obstruction~* Clinically relevant laboratory abnormalities (except for renal function tests or deviation of clinical laboratory values that are related to renal impairment)~* eGFR calculated by CKD-EPI formula ≥ 60 mL/min/1.73m2 and \\\\< 30 mL/min/1.73m2~For all subjects~* Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)~* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders~* History of relevant orthostatic hypotension, fainting spells, or blackouts~* Chronic or relevant acute infections~* History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)~* Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)~* Participation in another trial where an investigational drug has been administered within 30 days prior to planned administration of trial medication or longer if required by local regulation, or within 5-half-lives of the investigational agent taken (whichever is longer), or current participation in another trial involving administration of investigational drug~* Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)~* Inability to refrain from smoking on specified trial days~* Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males)~* Drug abuse or positive drug screening~* Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial~* Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial~* Inability to comply with dietary regimen of trial site~* A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening~* A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)~* Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study~Female subjects will not be allowed to participate if any of the following applies:~* Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after study completion~* Lactation period~Male subjects will not be allowed to participate if any of the following applies:~- Male subjects with WOCBP partner who are unwilling to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 725, Unnamed: 0: 907, NCT Number: NCT02172144, Study Title: Via Respimat® Inhaled BI 1744 CL Compared to Moxifloxacin and Placebo in Healthy Male and Female Volunteers, Study URL: https://clinicaltrials.gov/study/NCT02172144, Acronym: , Study Status: COMPLETED, Brief Summary: Study to investigate the effect of BI 1744 CL on the QT/QTc interval of the ECG (electrocardiogram) in comparison to placebo, Study Results: NO, Conditions: Healthy, Interventions: DRUG: BI 1744 CL solution for inhalation|DRUG: Placebo matching BI 1744 CL|DRUG: Moxifloxacin (Avalox®), Primary Outcome Measures: Change from baseline in the mean time-matched QTcI (QT interval, individually corrected according to the factor estimated from each subject), Baseline (day -1) and 20 to 120 min. after drug administration, Secondary Outcome Measures: Change of the QTcI at different point, Baseline (day -1) and 10 min. to 8 hours after drug administration|The mean of the QTcI values of all ECGs for Moxifloxacin and Placebo, 1 to 4 hours after drug administration, Other Outcome Measures: , Sponsor: Boehringer Ingelheim, Collaborators: , Sex: ALL, Age: ADULT, Phases: PHASE1, Enrollment: 24.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE|Primary Purpose: TREATMENT, Other IDs: 1222.8, Start Date: 2007-06, Primary Completion Date: 2007-10, Completion Date: , First Posted: 2014-06-24, Results First Posted: , Last Update Posted: 2014-06-24, Locations: , Study Documents: , criteria: "Inclusion Criteria:~All participants in the study will be healthy males or females, ranging from 21 to 50 years of age, with a body mass index (BMI) be within 18.5 to 29.9 kg/m2 (BMI calculation: weight in kilograms divided by the square of height in meters). In accordance with Good Clinical Practice and the local legislation all volunteers will have given their written informed consent prior to admission to the study~Exclusion Criteria:~* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, clinically relevant electrolyte disturbances~* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders~* History of orthostatic hypotension, fainting spells or blackouts~* Chronic or clinically relevant acute infections~* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator~* Intake of drugs with a long half-life (\\\\> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study~* Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study~* Participation in another trial with an investigational drug (within two months prior to administration or during the trial)~* Smoker (\\\\> 10 cigarettes or \\\\> 3 cigars of \\\\> 3 pipes/day)~* Inability to refrain from smoking on trial days~* Alcohol abuse (\\\\> 60 g/day for males and \\\\> 20 g/day for females)~* Drug abuse~* Blood donation (\\\\> 100 mL within four weeks prior to administration or during the trial)~* Any laboratory value outside the reference range if indicative of underlying disease or poor health~* Excessive physical activities within the last week before the trial or during the trial~* Hypersensitivity to treatment medication, moxifloxacin and/or related drugs of these classes~* Previous tendon disease related to quinolone treatment~* Congenital or documented acquired QT- prolongation, previous history of symptomatic arrhythmias~* Pulse rate at screening of \\\\> 80 bpm or \\\\< 45 bpm~* Any screening ECG value outside of the reference range of clinical relevance including, but not limited to PR (Pulse rate) interval \\\\> 220 ms, QRS interval \\\\> 115 ms, QTcB \\\\> 450 ms, or QT (uncorrected) \\\\> 470 ms~For Female Subjects:~* Pregnancy~* Positive pregnancy test~* No adequate contraception (adequate contraception e.g. sterilisation, intrauterine-pressure, oral contraceptives)~* Inability to maintain this adequate contraception during the whole study period~* Lactation period", combined_text: Via Respimat® Inhaled BI 1744 CL Compared to Moxifloxacin and Placebo in Healthy Male and Female Volunteers Change from baseline in the mean time-matched QTcI (QT interval, individually corrected according to the factor estimated from each subject), Baseline (day -1) and 20 to 120 min. after drug administration Change of the QTcI at different point, Baseline (day -1) and 10 min. to 8 hours after drug administration|The mean of the QTcI values of all ECGs for Moxifloxacin and Placebo, 1 to 4 hours after drug administration "Inclusion Criteria:~All participants in the study will be healthy males or females, ranging from 21 to 50 years of age, with a body mass index (BMI) be within 18.5 to 29.9 kg/m2 (BMI calculation: weight in kilograms divided by the square of height in meters). In accordance with Good Clinical Practice and the local legislation all volunteers will have given their written informed consent prior to admission to the study~Exclusion Criteria:~* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, clinically relevant electrolyte disturbances~* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders~* History of orthostatic hypotension, fainting spells or blackouts~* Chronic or clinically relevant acute infections~* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator~* Intake of drugs with a long half-life (\\\\> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study~* Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study~* Participation in another trial with an investigational drug (within two months prior to administration or during the trial)~* Smoker (\\\\> 10 cigarettes or \\\\> 3 cigars of \\\\> 3 pipes/day)~* Inability to refrain from smoking on trial days~* Alcohol abuse (\\\\> 60 g/day for males and \\\\> 20 g/day for females)~* Drug abuse~* Blood donation (\\\\> 100 mL within four weeks prior to administration or during the trial)~* Any laboratory value outside the reference range if indicative of underlying disease or poor health~* Excessive physical activities within the last week before the trial or during the trial~* Hypersensitivity to treatment medication, moxifloxacin and/or related drugs of these classes~* Previous tendon disease related to quinolone treatment~* Congenital or documented acquired QT- prolongation, previous history of symptomatic arrhythmias~* Pulse rate at screening of \\\\> 80 bpm or \\\\< 45 bpm~* Any screening ECG value outside of the reference range of clinical relevance including, but not limited to PR (Pulse rate) interval \\\\> 220 ms, QRS interval \\\\> 115 ms, QTcB \\\\> 450 ms, or QT (uncorrected) \\\\> 470 ms~For Female Subjects:~* Pregnancy~* Positive pregnancy test~* No adequate contraception (adequate contraception e.g. sterilisation, intrauterine-pressure, oral contraceptives)~* Inability to maintain this adequate contraception during the whole study period~* Lactation period", Similarity Score: 0.26284936888427396}'}]
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from_dataset
| 0.262849
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[{'from': 'human', 'value': '{Study Title: A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 1467335 is Processed in the Body, Primary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Time Interval From 0 to 24 Hours After Administration of the First Dose (AUC0-24), Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose AUC 0-24.\\n\\nStandard Error presented is actually geometric Standard Error. PKS-stat including participants data for AUC(0-24). The pharmacokinetic (PK) analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was defined as primary or secondary endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability., Pharmacokinetic (PK) samples were taken 2.00 hours (h) before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Maximum Measured Concentration of BI 1467335 in Plasma After Administration of the First Dose (Cmax), Maximum measured concentration of BI 1467335 in plasma after administration of the first dose (Cmax).\\n\\nStandard Error presented is actually geometric Standard Error., Pharmacokinetic (PK) samples were taken 2.00 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 28th Dose (AUCτ,28), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 28th dose (AUCτ,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 28th Dose (Cmax,28), Maximum measured concentration of BI 1467335 in plasma following administration of the 28th dose (Cmax,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28., Secondary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 14th Dose (AUCτ,14), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 14th dose (AUCτ,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 14th Dose (Cmax,14), Maximum measured concentration of BI 1467335 in plasma following administration of the 14th dose (Cmax,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14., criteria: "Inclusion Criteria:~* Despite of moderate renal impairment (Group 1) healthy male or female subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests~* Estimated glomerular filtration rate (eGFR) based on CKD-EPI formula for Group 1 between 30 and 59 mL/min/1.73m2 and for Group 2 ≥ 90 mL/min/1.73m2~* Age of 18 to 79 years (incl.)~* BMI of 18.5 to 34 kg/m2 (incl.)~* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation~* Male subjects, or female subjects who meet any of the following criteria (according to the CTFG Recommendations related to contraception and pregnancy testing in clinical trials, methods with a failure rate of less than 1% per year) starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion, e.g.:~ * Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives (inhibition of ovulation)~ * Hormonal intrauterine device~ * Sexually abstinent (defined as refraining from heterosexual intercourse during the entire period of risk)~ * A vasectomised sexual partner (provided that vasectomy was performed at least 1 year prior to enrolment and the vasectomised partner has received medical assessment of the surgical success)~ * Surgically sterilised (including bilateral tubal occlusion, hysterectomy)~ * Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)~Exclusion Criteria:~Healthy subjects~* Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator~* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm~* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance~* Any evidence of a concomitant disease judged as clinically relevant by the investigator~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Estimated glomerular filtration rate (eGFR) calculated by CKD-EPI formula \\\\< 90 mL/min/1.73m2~Subjects with moderate renal impairment~* Subject with significant diseases other than moderate renal impairment. A significant disease is defined as a disease which in the opinion of the investigator:~ * puts the subjects at risk because of participation in the study~ * may influence the results of the study~ * may influence the subject\\s ability to participate in the study~ * is not in a stable condition Diabetic or hypertensive subjects can be entered in this trial if the disease is not significant according to these criteria.~* Any finding of the medical examination (including BP, PR and ECG) of clinical relevance~* Moderate and severe concurrent liver function impairment (e.g. due to hepatorenal syndrome) or biliary obstruction~* Clinically relevant laboratory abnormalities (except for renal function tests or deviation of clinical laboratory values that are related to renal impairment)~* eGFR calculated by CKD-EPI formula ≥ 60 mL/min/1.73m2 and \\\\< 30 mL/min/1.73m2~For all subjects~* Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)~* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders~* History of relevant orthostatic hypotension, fainting spells, or blackouts~* Chronic or relevant acute infections~* History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)~* Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)~* Participation in another trial where an investigational drug has been administered within 30 days prior to planned administration of trial medication or longer if required by local regulation, or within 5-half-lives of the investigational agent taken (whichever is longer), or current participation in another trial involving administration of investigational drug~* Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)~* Inability to refrain from smoking on specified trial days~* Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males)~* Drug abuse or positive drug screening~* Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial~* Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial~* Inability to comply with dietary regimen of trial site~* A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening~* A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)~* Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study~Female subjects will not be allowed to participate if any of the following applies:~* Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after study completion~* Lactation period~Male subjects will not be allowed to participate if any of the following applies:~- Male subjects with WOCBP partner who are unwilling to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 656, Unnamed: 0: 816, NCT Number: NCT02214992, Study Title: Bioequivalence of Telmisartan/g Ramipril Fixed Dose Combination Compared With the Monocomponents Telmisartan and Ramipril (Two Different Formulations) Given Concomitantly to Healthy Male and Female Volunteers, Study URL: https://clinicaltrials.gov/study/NCT02214992, Acronym: , Study Status: COMPLETED, Brief Summary: Study to demonstrate the bioequivalence of 80 mg telmisartan/10 mg ramipril fixed dose combination versus its monocomponents given concurrently, Study Results: NO, Conditions: Healthy, Interventions: DRUG: Telmisartan/Ramipril|DRUG: Telmisartan|DRUG: Ramipril capsule|DRUG: Ramipril tablet, Primary Outcome Measures: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity), up to 96 hours after drug administration|Cmax (maximum measured concentration of the analyte in plasma), up to 96 hours after drug administration, Secondary Outcome Measures: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point), up to 96 hours after drug administration|AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval from t1 to t2), up to 96 hours after drug administration|tmax (time from dosing to the maximum concentration of the analyte in plasma), up to 96 hours after drug administration|λz (terminal rate constant in plasma), up to 96 hours after drug administration|t1/2 (terminal half-life of the analyte in plasma), up to 96 hours after drug administration|MRTpo (mean residence time of the analyte in the body after po administration), up to 96 hours after drug administration|CL/F (apparent clearance of the analyte in the plasma after extravascular administration), up to 96 hours after drug administration|Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose), up to 96 hours after drug administration|Number of patients with adverse events, up to 78 days|Number of patients with clinically relevant changes in laboratory tests, up to 78 days|Number of patients with clinically relevant changes in Vital Signs (Blood Pressure, Pulse Rate), up to 78 days|Number of patients with clinically relevant changes in 12-lead Electrocardiogram (ECG), up to 78 days|Assessment of ttolerability by investigator on a 4-point scale, Day 5 of each treatment, Other Outcome Measures: , Sponsor: Boehringer Ingelheim, Collaborators: , Sex: ALL, Age: ADULT, Phases: PHASE1, Enrollment: 84.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: 1236.5, Start Date: 2007-03, Primary Completion Date: 2007-06, Completion Date: , First Posted: 2014-08-13, Results First Posted: , Last Update Posted: 2014-08-13, Locations: , Study Documents: , criteria: "Inclusion Criteria:~* Healthy males and females according to the following criteria based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests~* Age ≥ 18 and Age ≤ 55 years~* BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)~* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation~Exclusion Criteria:~* Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance~* Any evidence of a clinically relevant concomitant disease~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Surgery of the gastrointestinal tract (except appendectomy)~* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders~* History of relevant orthostatic hypotension, fainting spells or blackouts~* Chronic or relevant acute infections~* History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)~* Intake of drugs with a long half-life (\\\\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial~* Use of drugs which might reasonably influence the results of the trial (especially unspecific inducing agents like St.John´s wort (Hypericum perforatum) or inhibitors like cimetidine) or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial~* Participation in another trial with an investigational drug within two months prior to administration or during the trial~* Smoker (\\\\> 10 cigarettes or \\\\> 3 cigars or \\\\> 3 pipes/day)~* Inability to refrain from smoking during 24 hours prior to dosing and 24 hours after dosing~* Alcohol abuse (more than 60 g/day) or inability to stop alcoholic beverages for 24 hours prior to dosing and up to the last sampling time point, 96 hours after dosing~* Drug abuse~* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)~* Excessive physical activities (within one week prior to administration or during the trial)~* Any laboratory value outside the reference range that is of clinical relevance~* Inability to comply with dietary regimen of trial site~* A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \\\\>450 ms)~* A history of additional risk factors for torsade de pointes (e.g., heart failure, hyperkalemia, hypokalemia, family history of Long QT Syndrome)~* Any history of relevant low blood pressure~* Supine blood pressure at screening of systolic \\\\<110 mm Hg and diastolic \\\\<60 mm Hg~* History of urticaria~* History of angioneurotic edema~* Hereditary fructose intolerance~For female subjects:~* Pregnancy or planning to become pregnant during the study or within 2 months of study completion~* Positive pregnancy test~* Are not willing or are unable to use a reliable method of contraception (such as implants, injectables and combined oral contraceptives, sterilisation, intrauterine device, double barrier method, sexual abstinence) for at least 1 month prior to participation in the trial, during and up to 1 month after completion/termination of the trial~* Chronic use of oral contraception or hormone replacement containing ethinyl estradiol as the only method of contraception~* Currently lactating", combined_text: Bioequivalence of Telmisartan/g Ramipril Fixed Dose Combination Compared With the Monocomponents Telmisartan and Ramipril (Two Different Formulations) Given Concomitantly to Healthy Male and Female Volunteers AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity), up to 96 hours after drug administration|Cmax (maximum measured concentration of the analyte in plasma), up to 96 hours after drug administration AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point), up to 96 hours after drug administration|AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval from t1 to t2), up to 96 hours after drug administration|tmax (time from dosing to the maximum concentration of the analyte in plasma), up to 96 hours after drug administration|λz (terminal rate constant in plasma), up to 96 hours after drug administration|t1/2 (terminal half-life of the analyte in plasma), up to 96 hours after drug administration|MRTpo (mean residence time of the analyte in the body after po administration), up to 96 hours after drug administration|CL/F (apparent clearance of the analyte in the plasma after extravascular administration), up to 96 hours after drug administration|Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose), up to 96 hours after drug administration|Number of patients with adverse events, up to 78 days|Number of patients with clinically relevant changes in laboratory tests, up to 78 days|Number of patients with clinically relevant changes in Vital Signs (Blood Pressure, Pulse Rate), up to 78 days|Number of patients with clinically relevant changes in 12-lead Electrocardiogram (ECG), up to 78 days|Assessment of ttolerability by investigator on a 4-point scale, Day 5 of each treatment "Inclusion Criteria:~* Healthy males and females according to the following criteria based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests~* Age ≥ 18 and Age ≤ 55 years~* BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)~* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation~Exclusion Criteria:~* Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance~* Any evidence of a clinically relevant concomitant disease~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Surgery of the gastrointestinal tract (except appendectomy)~* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders~* History of relevant orthostatic hypotension, fainting spells or blackouts~* Chronic or relevant acute infections~* History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)~* Intake of drugs with a long half-life (\\\\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial~* Use of drugs which might reasonably influence the results of the trial (especially unspecific inducing agents like St.John´s wort (Hypericum perforatum) or inhibitors like cimetidine) or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial~* Participation in another trial with an investigational drug within two months prior to administration or during the trial~* Smoker (\\\\> 10 cigarettes or \\\\> 3 cigars or \\\\> 3 pipes/day)~* Inability to refrain from smoking during 24 hours prior to dosing and 24 hours after dosing~* Alcohol abuse (more than 60 g/day) or inability to stop alcoholic beverages for 24 hours prior to dosing and up to the last sampling time point, 96 hours after dosing~* Drug abuse~* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)~* Excessive physical activities (within one week prior to administration or during the trial)~* Any laboratory value outside the reference range that is of clinical relevance~* Inability to comply with dietary regimen of trial site~* A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \\\\>450 ms)~* A history of additional risk factors for torsade de pointes (e.g., heart failure, hyperkalemia, hypokalemia, family history of Long QT Syndrome)~* Any history of relevant low blood pressure~* Supine blood pressure at screening of systolic \\\\<110 mm Hg and diastolic \\\\<60 mm Hg~* History of urticaria~* History of angioneurotic edema~* Hereditary fructose intolerance~For female subjects:~* Pregnancy or planning to become pregnant during the study or within 2 months of study completion~* Positive pregnancy test~* Are not willing or are unable to use a reliable method of contraception (such as implants, injectables and combined oral contraceptives, sterilisation, intrauterine device, double barrier method, sexual abstinence) for at least 1 month prior to participation in the trial, during and up to 1 month after completion/termination of the trial~* Chronic use of oral contraception or hormone replacement containing ethinyl estradiol as the only method of contraception~* Currently lactating", Similarity Score: 0.22946490633872416}'}]
|
from_dataset
| 0.229465
|
[{'from': 'human', 'value': '{Study Title: A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 1467335 is Processed in the Body, Primary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Time Interval From 0 to 24 Hours After Administration of the First Dose (AUC0-24), Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose AUC 0-24.\\n\\nStandard Error presented is actually geometric Standard Error. PKS-stat including participants data for AUC(0-24). The pharmacokinetic (PK) analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was defined as primary or secondary endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability., Pharmacokinetic (PK) samples were taken 2.00 hours (h) before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Maximum Measured Concentration of BI 1467335 in Plasma After Administration of the First Dose (Cmax), Maximum measured concentration of BI 1467335 in plasma after administration of the first dose (Cmax).\\n\\nStandard Error presented is actually geometric Standard Error., Pharmacokinetic (PK) samples were taken 2.00 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 28th Dose (AUCτ,28), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 28th dose (AUCτ,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 28th Dose (Cmax,28), Maximum measured concentration of BI 1467335 in plasma following administration of the 28th dose (Cmax,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28., Secondary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 14th Dose (AUCτ,14), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 14th dose (AUCτ,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 14th Dose (Cmax,14), Maximum measured concentration of BI 1467335 in plasma following administration of the 14th dose (Cmax,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14., criteria: "Inclusion Criteria:~* Despite of moderate renal impairment (Group 1) healthy male or female subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests~* Estimated glomerular filtration rate (eGFR) based on CKD-EPI formula for Group 1 between 30 and 59 mL/min/1.73m2 and for Group 2 ≥ 90 mL/min/1.73m2~* Age of 18 to 79 years (incl.)~* BMI of 18.5 to 34 kg/m2 (incl.)~* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation~* Male subjects, or female subjects who meet any of the following criteria (according to the CTFG Recommendations related to contraception and pregnancy testing in clinical trials, methods with a failure rate of less than 1% per year) starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion, e.g.:~ * Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives (inhibition of ovulation)~ * Hormonal intrauterine device~ * Sexually abstinent (defined as refraining from heterosexual intercourse during the entire period of risk)~ * A vasectomised sexual partner (provided that vasectomy was performed at least 1 year prior to enrolment and the vasectomised partner has received medical assessment of the surgical success)~ * Surgically sterilised (including bilateral tubal occlusion, hysterectomy)~ * Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)~Exclusion Criteria:~Healthy subjects~* Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator~* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm~* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance~* Any evidence of a concomitant disease judged as clinically relevant by the investigator~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Estimated glomerular filtration rate (eGFR) calculated by CKD-EPI formula \\\\< 90 mL/min/1.73m2~Subjects with moderate renal impairment~* Subject with significant diseases other than moderate renal impairment. A significant disease is defined as a disease which in the opinion of the investigator:~ * puts the subjects at risk because of participation in the study~ * may influence the results of the study~ * may influence the subject\\s ability to participate in the study~ * is not in a stable condition Diabetic or hypertensive subjects can be entered in this trial if the disease is not significant according to these criteria.~* Any finding of the medical examination (including BP, PR and ECG) of clinical relevance~* Moderate and severe concurrent liver function impairment (e.g. due to hepatorenal syndrome) or biliary obstruction~* Clinically relevant laboratory abnormalities (except for renal function tests or deviation of clinical laboratory values that are related to renal impairment)~* eGFR calculated by CKD-EPI formula ≥ 60 mL/min/1.73m2 and \\\\< 30 mL/min/1.73m2~For all subjects~* Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)~* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders~* History of relevant orthostatic hypotension, fainting spells, or blackouts~* Chronic or relevant acute infections~* History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)~* Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)~* Participation in another trial where an investigational drug has been administered within 30 days prior to planned administration of trial medication or longer if required by local regulation, or within 5-half-lives of the investigational agent taken (whichever is longer), or current participation in another trial involving administration of investigational drug~* Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)~* Inability to refrain from smoking on specified trial days~* Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males)~* Drug abuse or positive drug screening~* Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial~* Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial~* Inability to comply with dietary regimen of trial site~* A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening~* A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)~* Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study~Female subjects will not be allowed to participate if any of the following applies:~* Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after study completion~* Lactation period~Male subjects will not be allowed to participate if any of the following applies:~- Male subjects with WOCBP partner who are unwilling to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 348, Unnamed: 0: 422, NCT Number: NCT02220673, Study Title: Serial Lung Function Measurements in Healthy and Mild Asthmatic Adults After Oral Inhalation of Ethanolic Solutions Containing Two Concentrations of the Excipient Butylated Hydroxytoluene (BHT) Administered With the Respimat® B (RMT-B), Study URL: https://clinicaltrials.gov/study/NCT02220673, Acronym: , Study Status: COMPLETED, Brief Summary: Primary objective: To investigate the safety and local tolerability of increasing cumulative doses (2, 4, 6 actuations) of a low (0.1%) and a high (0.5%) concentration of BHT administered via oral inhalation with the Respimat® inhaler B (RMT-B) vs. 2 inhalation solutions without BHT (placebo to BHT given by RMT B and placebo given by hydroxylfluoralkane metered dose inhaler (HFA MDI)). In a first step, the trial was performed in healthy subjects and - if no safety concerns arose - in a second step in patients with mild asthma who were sensitive to metacholine in a respective challenge test. Secondary objective: To explore the pharmacokinetics (PK) of BHT., Study Results: NO, Conditions: Asthma, Interventions: DRUG: BHT 0.1%|DRUG: BHT 0.5%|DRUG: Placebo for RMT-B|DRUG: Placebo for HFA-MDI, Primary Outcome Measures: Maximum decrease of forced expiratory volume in one second (FEV1), (Minimum FEV1 value over the interval 5 min to 2 h 50 min) minus (baseline value), baseline, 3 h after administration, Secondary Outcome Measures: Maximum decrease in FEV1 after 2 actuations, (minimum FEV1 value over the interval 5 min to 50 min) - (baseline value), baseline, up to 50 minutes after drug administration|Maximum decrease in FEV1 after 4 actuations, (minimum FEV1 value over the interval 1 h 5 min to 1 h 50 min) - (baseline value), baseline, up to 1:50 hours after drug administration|Maximum decrease in FEV1 after 6 actuations, (minimum FEV1 value over the interval 2 h 5 min to 2 h 50 min) - (baseline value), baseline, up to 2:50 hours after drug administration|Number of subjects with a decrease in FEV1, stratified into classes of 0-20%, \\\\>20-40%, and \\\\>40%, baseline, up to 2:50 hours after drug administration|Number of patients with cough episodes, within 5 min prior to the 1st inhalation and within 5 min after each of the 3 inhalations on each treatment day, up to 9 days|Number of patients requiring rescue medication, up to 60 min after each dosing|Number of patients with adverse events, up to 10 days after the last treatment day|Cmax (maximum measured concentration of the analyte in plasma), pre-dose, 2, 10, 25 and 55 min after each dosing|tmax (time from dosing to maximum measured concentration of the analyte in plasma), pre-dose, 2, 10, 25 and 55 min after each dosing|AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz), pre-dose, 2, 10, 25 and 55 min after each dosing|Area under the curve (AUC) of FEV1, over 3 hours after first dosing|AUC of FEV1, over 1 hours after each dosing, Other Outcome Measures: , Sponsor: Boehringer Ingelheim, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE1, Enrollment: 61.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE|Primary Purpose: TREATMENT, Other IDs: 1256.13, Start Date: 2009-11, Primary Completion Date: 2010-05, Completion Date: , First Posted: 2014-08-20, Results First Posted: , Last Update Posted: 2014-08-20, Locations: , Study Documents: , criteria: "Inclusion Criteria:~Healthy subjects~* Male or female adult subjects~* Age ≥ 18 and ≤ 65 years~* Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2~* Non-smokers (within the last 5 years)~* Signed and dated written informed consent prior to admission to the trial in accordance with Good Clinical Practice (GCP) and the local legislation~* Proper use of RMT and MDI~* Able to perform technically satisfactory pulmonary function test~Patients with mild asthma~* Male or female adult subjects with intermittent and mild persistent asthma~* Age ≥ 18 and ≤ 65 years~* Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2~* FEV1 ≥ 70% predicted and stable for at least 7 days prior to randomization~* Short acting beta agonist (SABA) response documented in the last 6 months~* A history of wheeze, cough, dyspnoea or chest tightness following exposure to at least one of the following: cold, exercise, dry air, smoke, dust, allergens~* Positive methacholine challenge test reflecting mild to moderate bronchial hyperreactivity (PC20: 0.25-4.0 mg/mL) performed within two weeks prior randomization (at visit 1 or between visit 1 and 2)~* None or stable dosages of pulmonary medications (SABA only) in the past 6 weeks~* Non smokers or ex-smokers for the last 5 years~* Signed and dated written informed consent prior to admission to the trial in accordance with GCP and the local legislation~* Proper use of RMT and MDI~* Able to perform technically satisfactory pulmonary function test~Exclusion Criteria:~Healthy subjects~* Any finding in the medical examination (including blood pressure (BP), pulse rate (PR)) deviating from normal and of clinical relevance~* Any laboratory value outside the reference range deemed of clinical relevance~* Pregnant or breast feeding women or women of childbearing potential without having a negative Human choriongonadotropin, β-subunit (ß-HCG) pregnancy test and without using a medically approved highly effective method of contraception for the previous 3 months~* Abnormal spirometry i.e., FEV1 \\\\<80% predicted and/or methacholine challenge at screening Visit 1 (or between Visits 1 and 2)~* Acute or chronic bacterial and viral infections of the lung~* History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)~* Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Clinically relevant diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders~* Use of drugs which might reasonably influence the results of the trial within 10 days prior to first administration or during the trial (assessed and judged by the investigator)~* Participation in another trial with an investigational drug within 1 month prior to administration or during the trial~* Alcohol abuse (more than 60 g/day)~* Drug abuse~* Blood donation (\\\\>120 mL within 4 weeks prior to administration or during the trial)~* Excessive physical activities (within 1 week prior to administration or during the trial)~* Any vulnerable subjects~* Inability to comply with protocol requirements, instructions and study related restrictions, dietary regimen of trial site, and improbability of completing the study~Patients with mild asthma~* Any finding of the medical examination (including BP, PR) deviating from normal and of clinical relevance~* Any laboratory value that was of clinical relevance~* Moderate or severe persistent asthma~* Pregnant or breast feeding women or women of childbearing potential without a negative ß-HCG pregnancy test and without using a medically approved highly effective method of contraception for the previous 3 months~* Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Clinically relevant diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders~* Chronic or relevant acute infections~* Treated or non-treated bacterial and viral infections of the lung, including active or latent tuberculosis~* Use of any corticosteroids, long acting muscarinic antagonist (LAMA) or long acting beta agonists (LABA), all within 1 month prior to screening Visit 1 and prior to administration of investigational product (i.e., allergic patients could only participate outside their season)~* Clinically relevant perennial allergies (i.e., which need actual treatment)~* Methylxanthines, antihistamines, antileukotrienes, cromolyn/nedocromil sodium all within 1 month prior to screening Visit 1 and prior to administration of investigational product~* SABAs 12 h prior to each visit day~* Use of other drugs which reasonably influence the results of the trial within 10 days prior to first administration or during the trial (e.g., beta blockers, all antimuscarinic agents like phenothiazines and some antidepressants)~* Participation in another trial with an investigational product within 1 month prior to administration or during the trial~* Alcohol abuse (more than 60 g/day)~* Drug abuse~* Blood donation (\\\\>120 mL within 4 weeks prior to administration or during the trial)~* Excessive physical activities (within 3 days prior to administration or during the trial)~* Inability to comply with protocol requirements, instructions and trial related restrictions, dietary regimen of trial site, and improbability of completing the trial~* Any vulnerable patients", combined_text: Serial Lung Function Measurements in Healthy and Mild Asthmatic Adults After Oral Inhalation of Ethanolic Solutions Containing Two Concentrations of the Excipient Butylated Hydroxytoluene (BHT) Administered With the Respimat® B (RMT-B) Maximum decrease of forced expiratory volume in one second (FEV1), (Minimum FEV1 value over the interval 5 min to 2 h 50 min) minus (baseline value), baseline, 3 h after administration Maximum decrease in FEV1 after 2 actuations, (minimum FEV1 value over the interval 5 min to 50 min) - (baseline value), baseline, up to 50 minutes after drug administration|Maximum decrease in FEV1 after 4 actuations, (minimum FEV1 value over the interval 1 h 5 min to 1 h 50 min) - (baseline value), baseline, up to 1:50 hours after drug administration|Maximum decrease in FEV1 after 6 actuations, (minimum FEV1 value over the interval 2 h 5 min to 2 h 50 min) - (baseline value), baseline, up to 2:50 hours after drug administration|Number of subjects with a decrease in FEV1, stratified into classes of 0-20%, \\\\>20-40%, and \\\\>40%, baseline, up to 2:50 hours after drug administration|Number of patients with cough episodes, within 5 min prior to the 1st inhalation and within 5 min after each of the 3 inhalations on each treatment day, up to 9 days|Number of patients requiring rescue medication, up to 60 min after each dosing|Number of patients with adverse events, up to 10 days after the last treatment day|Cmax (maximum measured concentration of the analyte in plasma), pre-dose, 2, 10, 25 and 55 min after each dosing|tmax (time from dosing to maximum measured concentration of the analyte in plasma), pre-dose, 2, 10, 25 and 55 min after each dosing|AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz), pre-dose, 2, 10, 25 and 55 min after each dosing|Area under the curve (AUC) of FEV1, over 3 hours after first dosing|AUC of FEV1, over 1 hours after each dosing "Inclusion Criteria:~Healthy subjects~* Male or female adult subjects~* Age ≥ 18 and ≤ 65 years~* Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2~* Non-smokers (within the last 5 years)~* Signed and dated written informed consent prior to admission to the trial in accordance with Good Clinical Practice (GCP) and the local legislation~* Proper use of RMT and MDI~* Able to perform technically satisfactory pulmonary function test~Patients with mild asthma~* Male or female adult subjects with intermittent and mild persistent asthma~* Age ≥ 18 and ≤ 65 years~* Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2~* FEV1 ≥ 70% predicted and stable for at least 7 days prior to randomization~* Short acting beta agonist (SABA) response documented in the last 6 months~* A history of wheeze, cough, dyspnoea or chest tightness following exposure to at least one of the following: cold, exercise, dry air, smoke, dust, allergens~* Positive methacholine challenge test reflecting mild to moderate bronchial hyperreactivity (PC20: 0.25-4.0 mg/mL) performed within two weeks prior randomization (at visit 1 or between visit 1 and 2)~* None or stable dosages of pulmonary medications (SABA only) in the past 6 weeks~* Non smokers or ex-smokers for the last 5 years~* Signed and dated written informed consent prior to admission to the trial in accordance with GCP and the local legislation~* Proper use of RMT and MDI~* Able to perform technically satisfactory pulmonary function test~Exclusion Criteria:~Healthy subjects~* Any finding in the medical examination (including blood pressure (BP), pulse rate (PR)) deviating from normal and of clinical relevance~* Any laboratory value outside the reference range deemed of clinical relevance~* Pregnant or breast feeding women or women of childbearing potential without having a negative Human choriongonadotropin, β-subunit (ß-HCG) pregnancy test and without using a medically approved highly effective method of contraception for the previous 3 months~* Abnormal spirometry i.e., FEV1 \\\\<80% predicted and/or methacholine challenge at screening Visit 1 (or between Visits 1 and 2)~* Acute or chronic bacterial and viral infections of the lung~* History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)~* Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Clinically relevant diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders~* Use of drugs which might reasonably influence the results of the trial within 10 days prior to first administration or during the trial (assessed and judged by the investigator)~* Participation in another trial with an investigational drug within 1 month prior to administration or during the trial~* Alcohol abuse (more than 60 g/day)~* Drug abuse~* Blood donation (\\\\>120 mL within 4 weeks prior to administration or during the trial)~* Excessive physical activities (within 1 week prior to administration or during the trial)~* Any vulnerable subjects~* Inability to comply with protocol requirements, instructions and study related restrictions, dietary regimen of trial site, and improbability of completing the study~Patients with mild asthma~* Any finding of the medical examination (including BP, PR) deviating from normal and of clinical relevance~* Any laboratory value that was of clinical relevance~* Moderate or severe persistent asthma~* Pregnant or breast feeding women or women of childbearing potential without a negative ß-HCG pregnancy test and without using a medically approved highly effective method of contraception for the previous 3 months~* Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Clinically relevant diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders~* Chronic or relevant acute infections~* Treated or non-treated bacterial and viral infections of the lung, including active or latent tuberculosis~* Use of any corticosteroids, long acting muscarinic antagonist (LAMA) or long acting beta agonists (LABA), all within 1 month prior to screening Visit 1 and prior to administration of investigational product (i.e., allergic patients could only participate outside their season)~* Clinically relevant perennial allergies (i.e., which need actual treatment)~* Methylxanthines, antihistamines, antileukotrienes, cromolyn/nedocromil sodium all within 1 month prior to screening Visit 1 and prior to administration of investigational product~* SABAs 12 h prior to each visit day~* Use of other drugs which reasonably influence the results of the trial within 10 days prior to first administration or during the trial (e.g., beta blockers, all antimuscarinic agents like phenothiazines and some antidepressants)~* Participation in another trial with an investigational product within 1 month prior to administration or during the trial~* Alcohol abuse (more than 60 g/day)~* Drug abuse~* Blood donation (\\\\>120 mL within 4 weeks prior to administration or during the trial)~* Excessive physical activities (within 3 days prior to administration or during the trial)~* Inability to comply with protocol requirements, instructions and trial related restrictions, dietary regimen of trial site, and improbability of completing the trial~* Any vulnerable patients", Similarity Score: 0.21924536462490632}'}]
|
from_dataset
| 0.219245
|
[{'from': 'human', 'value': '{Study Title: A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 1467335 is Processed in the Body, Primary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Time Interval From 0 to 24 Hours After Administration of the First Dose (AUC0-24), Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose AUC 0-24.\\n\\nStandard Error presented is actually geometric Standard Error. PKS-stat including participants data for AUC(0-24). The pharmacokinetic (PK) analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was defined as primary or secondary endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability., Pharmacokinetic (PK) samples were taken 2.00 hours (h) before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Maximum Measured Concentration of BI 1467335 in Plasma After Administration of the First Dose (Cmax), Maximum measured concentration of BI 1467335 in plasma after administration of the first dose (Cmax).\\n\\nStandard Error presented is actually geometric Standard Error., Pharmacokinetic (PK) samples were taken 2.00 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 28th Dose (AUCτ,28), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 28th dose (AUCτ,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 28th Dose (Cmax,28), Maximum measured concentration of BI 1467335 in plasma following administration of the 28th dose (Cmax,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28., Secondary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 14th Dose (AUCτ,14), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 14th dose (AUCτ,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 14th Dose (Cmax,14), Maximum measured concentration of BI 1467335 in plasma following administration of the 14th dose (Cmax,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14., criteria: "Inclusion Criteria:~* Despite of moderate renal impairment (Group 1) healthy male or female subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests~* Estimated glomerular filtration rate (eGFR) based on CKD-EPI formula for Group 1 between 30 and 59 mL/min/1.73m2 and for Group 2 ≥ 90 mL/min/1.73m2~* Age of 18 to 79 years (incl.)~* BMI of 18.5 to 34 kg/m2 (incl.)~* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation~* Male subjects, or female subjects who meet any of the following criteria (according to the CTFG Recommendations related to contraception and pregnancy testing in clinical trials, methods with a failure rate of less than 1% per year) starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion, e.g.:~ * Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives (inhibition of ovulation)~ * Hormonal intrauterine device~ * Sexually abstinent (defined as refraining from heterosexual intercourse during the entire period of risk)~ * A vasectomised sexual partner (provided that vasectomy was performed at least 1 year prior to enrolment and the vasectomised partner has received medical assessment of the surgical success)~ * Surgically sterilised (including bilateral tubal occlusion, hysterectomy)~ * Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)~Exclusion Criteria:~Healthy subjects~* Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator~* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm~* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance~* Any evidence of a concomitant disease judged as clinically relevant by the investigator~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Estimated glomerular filtration rate (eGFR) calculated by CKD-EPI formula \\\\< 90 mL/min/1.73m2~Subjects with moderate renal impairment~* Subject with significant diseases other than moderate renal impairment. A significant disease is defined as a disease which in the opinion of the investigator:~ * puts the subjects at risk because of participation in the study~ * may influence the results of the study~ * may influence the subject\\s ability to participate in the study~ * is not in a stable condition Diabetic or hypertensive subjects can be entered in this trial if the disease is not significant according to these criteria.~* Any finding of the medical examination (including BP, PR and ECG) of clinical relevance~* Moderate and severe concurrent liver function impairment (e.g. due to hepatorenal syndrome) or biliary obstruction~* Clinically relevant laboratory abnormalities (except for renal function tests or deviation of clinical laboratory values that are related to renal impairment)~* eGFR calculated by CKD-EPI formula ≥ 60 mL/min/1.73m2 and \\\\< 30 mL/min/1.73m2~For all subjects~* Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)~* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders~* History of relevant orthostatic hypotension, fainting spells, or blackouts~* Chronic or relevant acute infections~* History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)~* Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)~* Participation in another trial where an investigational drug has been administered within 30 days prior to planned administration of trial medication or longer if required by local regulation, or within 5-half-lives of the investigational agent taken (whichever is longer), or current participation in another trial involving administration of investigational drug~* Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)~* Inability to refrain from smoking on specified trial days~* Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males)~* Drug abuse or positive drug screening~* Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial~* Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial~* Inability to comply with dietary regimen of trial site~* A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening~* A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)~* Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study~Female subjects will not be allowed to participate if any of the following applies:~* Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after study completion~* Lactation period~Male subjects will not be allowed to participate if any of the following applies:~- Male subjects with WOCBP partner who are unwilling to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 206, Unnamed: 0: 251, NCT Number: NCT04789291, Study Title: A Study in Healthy Men to Test How BI 1595043 is Taken up in the Body When Given With or Without Food, Study URL: https://clinicaltrials.gov/study/NCT04789291, Acronym: , Study Status: COMPLETED, Brief Summary: The main objective of this trial is to investigate the relative bioavailability of BI 1595043 under fed state (Test, T) and under fasted state (Reference, R)., Study Results: YES, Conditions: Healthy, Interventions: DRUG: BI 1595043, Primary Outcome Measures: "Area Under the Concentration-time Curve of BI 1595043 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz), Area under the concentration-time curve of BI 1595043 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported.\\n\\nThe statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data was logtransformed (natural logarithm) prior to fitting the ANOVA model.This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed., Within 3 hours before drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120, 144 and 168 hours following drug administration.|Maximum Measured Concentration of BI 1595043 in Plasma (Cmax), Maximum measured concentration of BI 1595043 in plasma (Cmax) is reported.\\n\\nThe statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data was logtransformed (natural logarithm) prior to fitting the ANOVA model.This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed., Within 3 hours before drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120, 144 and 168 hours following drug administration.", Secondary Outcome Measures: "Area Under the Concentration-time Curve of BI 1595043 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞), Area under the concentration-time curve of BI 1595043 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.\\n\\nThe statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data was logtransformed (natural logarithm) prior to fitting the ANOVA model.This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed., Within 3 hours before drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120, 144 and 168 hours following drug administration.", Other Outcome Measures: , Sponsor: Boehringer Ingelheim, Collaborators: , Sex: MALE, Age: ADULT, Phases: PHASE1, Enrollment: 13.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: 1445-0011|2020-004924-40, Start Date: 2021-05-18, Primary Completion Date: 2021-08-07, Completion Date: 2021-08-07, First Posted: 2021-03-09, Results First Posted: 2024-02-22, Last Update Posted: 2024-02-22, Locations: SGS Life Science Services - Clinical Research, Edegem, 2650, Belgium, Study Documents: Study Protocol, https://cdn.clinicaltrials.gov/large-docs/91/NCT04789291/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/91/NCT04789291/SAP_001.pdf, criteria: "Inclusion Criteria:~* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature), 12-lead electrocardiogram (ECG), and clinical laboratory tests~* Age of 18 to 50 years (inclusive)~* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)~* Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation~* Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:~ * Use of adequate contraception, i.e. use of condom (male subjects) plus any of the following methods (female partners): intrauterine device, hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to first drug administration to the male subject, or barrier method (e.g. diaphragm with spermicide), or surgically sterilised (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy), or postmenopausal, defined as at least 1 year of spontaneous amenorrhea~ * Sexually abstinent~ * Vasectomised (vasectomy at least 1 year prior to enrolment) in combination with a barrier method (i.e. condom) Unprotected sexual intercourse (i.e. without use of condom) with a pregnant female partner and sperm donation is not allowed throughout the study and until 30 days after trial completion~Exclusion Criteria:~* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator~* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)~* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance~* Any evidence of a concomitant disease assessed as clinically relevant by the investigator~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)~* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders~* History of relevant orthostatic hypotension, fainting spells, or blackouts~* Further exclusion criteria apply", combined_text: A Study in Healthy Men to Test How BI 1595043 is Taken up in the Body When Given With or Without Food Area Under the Concentration-time Curve of BI 1595043 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz), Area under the concentration-time curve of BI 1595043 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported.\\n\\nThe statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data was logtransformed (natural logarithm) prior to fitting the ANOVA model.This model included effects accounting for the following sources of variation: \\sequence\\, \\subjects within sequences\\, \\period\\ and \\treatment\\. The effect \\subjects within sequences\\ was considered as random, whereas the other effects were considered as fixed., Within 3 hours before drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120, 144 and 168 hours following drug administration.|Maximum Measured Concentration of BI 1595043 in Plasma (Cmax), Maximum measured concentration of BI 1595043 in plasma (Cmax) is reported.\\n\\nThe statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data was logtransformed (natural logarithm) prior to fitting the ANOVA model.This model included effects accounting for the following sources of variation: \\sequence\\, \\subjects within sequences\\, \\period\\ and \\treatment\\. The effect \\subjects within sequences\\ was considered as random, whereas the other effects were considered as fixed., Within 3 hours before drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120, 144 and 168 hours following drug administration. Area Under the Concentration-time Curve of BI 1595043 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞), Area under the concentration-time curve of BI 1595043 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.\\n\\nThe statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data was logtransformed (natural logarithm) prior to fitting the ANOVA model.This model included effects accounting for the following sources of variation: \\sequence\\, \\subjects within sequences\\, \\period\\ and \\treatment\\. The effect \\subjects within sequences\\ was considered as random, whereas the other effects were considered as fixed., Within 3 hours before drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120, 144 and 168 hours following drug administration. "Inclusion Criteria:~* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature), 12-lead electrocardiogram (ECG), and clinical laboratory tests~* Age of 18 to 50 years (inclusive)~* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)~* Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation~* Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:~ * Use of adequate contraception, i.e. use of condom (male subjects) plus any of the following methods (female partners): intrauterine device, hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to first drug administration to the male subject, or barrier method (e.g. diaphragm with spermicide), or surgically sterilised (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy), or postmenopausal, defined as at least 1 year of spontaneous amenorrhea~ * Sexually abstinent~ * Vasectomised (vasectomy at least 1 year prior to enrolment) in combination with a barrier method (i.e. condom) Unprotected sexual intercourse (i.e. without use of condom) with a pregnant female partner and sperm donation is not allowed throughout the study and until 30 days after trial completion~Exclusion Criteria:~* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator~* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)~* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance~* Any evidence of a concomitant disease assessed as clinically relevant by the investigator~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)~* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders~* History of relevant orthostatic hypotension, fainting spells, or blackouts~* Further exclusion criteria apply", Similarity Score: 0.21737232971614914}'}]
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| 0.217372
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"[{'from': 'human', 'value': '{Study Title: A Study in People With Normal Kidney Function and People(...TRUNCATED)
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"[{'from': 'human', 'value': '{Study Title: A Study in People With Normal Kidney Function and People(...TRUNCATED)
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from_dataset
| 0.205866
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