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临床试验/NCT02171494
NCT02171494已完成1 期

Bioequivalence of 2x5 mg of IVAX Warfarin /Formulation Tablet Compared to 10 mg of Coumadin /Formulation Tablet Following Oral Administration in Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Two-treatment, Two-sequence Crossover Study) Under Fasted Conditions

Boehringer Ingelheim0 个研究点目标入组 36 人开始时间: 2008年9月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
36
主要终点
AUC0-infinity (area under the concentration-time curve over the time interval from 0 extrapolated to infinity)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

To establish the bioequivalence of 2x5 mg of IVAX warfarin /formulation tablet vs. 10 mg of Coumadin / formulation tablet

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years（Adult）
性别
Male
接受健康志愿者
是

入选标准

  • •Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate, temp), 12-lead electrocardiogram, clinical laboratory tests, without clinically significant abnormal findings
  • •Age ≥ 18 and Age ≤ 45 years
  • •Body Mass Index (BMI) ≥ 18.0 and BMI ≤ 30.0 kg/m2
  • •Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation

排除标准

  • •A history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results
  • •A history of allergic or adverse responses to warfarin or any comparable or similar product
  • •Subjects who (for whatever reason) had been on an abnormal diet or had substantial changes in eating habits within 30 days prior to study initiation
  • •Subjects could not have made a blood donation of one pint or more within 30 days prior to study initiation
  • •Subjects could not have made a plasma donation within 14 days of study initiation
  • •Participation in a clinical trial within 30 days prior to study initiation
  • •Use of any over-the-counter (OTC) medication, including vitamins, herbal products, and dietary supplements, within 7 days prior to or during the study
  • •Use of any prescription medication within 7 days prior to or during the study
  • •Treatment with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, phenytoin, rifampin, rifabutin, glucocorticoids, diltiazem, ketoconazole, MAOI (monoamine oxidase inhibitor), antidepressants, neuroleptics, verapamil, quinidine, erythromycin, etc., within 30 days prior to or during the study
  • •Smoking or use of tobacco products within 6 months prior to or during the study. Smoking status was verified by a urine cotinine screen.
  • •Female subjects
  • •Positive blood screen for Human Immunodeficiency Virus, Hepatitis B, or Hepatitis C
  • •Positive screen for alcohol, drugs of abuse, or cotinine and history or presence of alcoholism or drug abuse within 6 months prior to the study start
  • •Subjects could not have taken aspirin or any aspirin-containing medications or any antiplatelet or anticoagulant medication within 7 days prior to the study, for the duration of the study and for 14 days after the last dose of study medication
  • •aPTT (activated partial thromboplastin time) or INR (international normalized ratio) results unacceptable to principal investigator
  • •Inability to comply with dietary regimen of trial site

研究组 & 干预措施

IVAX warfarin

Experimental

Treatment A: IVAX warfarin

干预措施: IVAX Warfarin (Drug)

BMS coumadin

Active Comparator

Treatment B: BMS coumadin tablets

干预措施: BMS Coumadin (Drug)

结局指标

主要结局

AUC0-infinity (area under the concentration-time curve over the time interval from 0 extrapolated to infinity)

时间窗: pre-dose and 0:15, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 5:00, 6:00, 8:00,10:00 12:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 and 216:00 hours after dosing on day 1 and day 22

Cmax (maximum measured concentration of the analyte in plasma)

时间窗: pre-dose and 0:15, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 5:00, 6:00, 8:00,10:00 12:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 and 216:00 hours after dosing on day 1 and day 22

次要结局

  • AUC0-tz (area under the concentration-time curve over the time interval from 0 to the time of the last quantifiable data point)(pre-dose and 0:15, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 5:00, 6:00, 8:00,10:00 12:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 and 216:00 hours after dosing on day 1 and day 22)
  • tmax (time from dosing to the maximum concentration)(pre-dose and 0:15, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 5:00, 6:00, 8:00,10:00 12:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 and 216:00 hours after dosing on day 1 and day 22)
  • λz (terminal rate constant in plasma)(pre-dose and 0:15, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 5:00, 6:00, 8:00,10:00 12:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 and 216:00 hours after dosing on day 1 and day 22)
  • t1/2 (terminal half-life of the analyte in plasma)(pre-dose and 0:15, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 5:00, 6:00, 8:00,10:00 12:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 and 216:00 hours after dosing on day 1 and day 22)
  • MRTpo (mean residence time of the analyte in the body after oral administration)(pre-dose and 0:15, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 5:00, 6:00, 8:00,10:00 12:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 and 216:00 hours after dosing on day 1 and day 22)
  • CL/F (apparent clearance after extravascular administration)(pre-dose and 0:15, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 5:00, 6:00, 8:00,10:00 12:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 and 216:00 hours after dosing on day 1 and day 22)
  • Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)(pre-dose and 0:15, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 5:00, 6:00, 8:00,10:00 12:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 and 216:00 hours after dosing on day 1 and day 22)

研究者

申办方类型
Industry
责任方
Sponsor

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