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Trial record 52 of 590 for:    WARFARIN

Bioequivalence of IVAX Warfarin Tablets and Coumadin Brand Warfarin Tablets in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02171494
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : June 24, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Healthy Drug: IVAX Warfarin Drug: BMS Coumadin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2008
Actual Primary Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: IVAX warfarin
Treatment A: IVAX warfarin
Drug: IVAX Warfarin
Active Comparator: BMS coumadin
Treatment B: BMS coumadin tablets
Drug: BMS Coumadin



Primary Outcome Measures :
  1. AUC0-infinity (area under the concentration-time curve over the time interval from 0 extrapolated to infinity) [ Time Frame: 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 ]
  2. Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: 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 ]

Secondary Outcome Measures :
  1. AUC0-tz (area under the concentration-time curve over the time interval from 0 to the time of the last quantifiable data point) [ Time Frame: 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 ]
  2. tmax (time from dosing to the maximum concentration) [ Time Frame: 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 ]
  3. λz (terminal rate constant in plasma) [ Time Frame: 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 ]
  4. t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: 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 ]
  5. MRTpo (mean residence time of the analyte in the body after oral administration) [ Time Frame: 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 ]
  6. CL/F (apparent clearance after extravascular administration) [ Time Frame: 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 ]
  7. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) [ Time Frame: 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 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02171494     History of Changes
Other Study ID Numbers: 1160.68
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: June 24, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Warfarin
Anticoagulants