Relative Bioavailability Study of Ribavirin 200 Capsules and Rebetol 200 mg Capsules in Females Under Non-Fasting Conditions
Phase 1
Completed
- Conditions
- Chronic Hepatitis C
- Interventions
- Registration Number
- NCT00959933
- Lead Sponsor
- Sandoz
- Brief Summary
The purpose of this study is to demonstrate the relative bioavailability of Ribavirin 200 capsules and Rebetol 200 mg capsules in females under non-fasting conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 24
Inclusion Criteria
- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
Exclusion Criteria
- Positive test results for HIV or hepatitis B or C.
- Treatment for drug or alcohol dependence.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 2 Rebetol 200 Capsules (Schering Corporation, U.S.A.) Rebetol 200 Capsules (Schering Corporation, U.S.A.) 1 Ribavirin 200 Capsules (Geneva Pharmaceutical, U.S.A.) Ribavirin 200 Capsules (Geneva Pharmaceutical, U.S.A.)
- Primary Outcome Measures
Name Time Method Bioequivalence based on AUC and Cmax 30 days
- Secondary Outcome Measures
Name Time Method