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

NCT ID: NCT02171494

Last Updated: 2014-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IVAX warfarin

Treatment A: IVAX warfarin

Group Type: EXPERIMENTAL

IVAX Warfarin

Intervention Type: DRUG

BMS coumadin

Treatment B: BMS coumadin tablets

Group Type: ACTIVE_COMPARATOR

BMS Coumadin

Intervention Type: DRUG

Interventions

IVAX Warfarin

Intervention Type: DRUG

BMS Coumadin

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1160.68

Identifier Type: -

Identifier Source: org_study_id