Relative Bioavailability Study of Ribavirin 200 Capsules and Rebetol 200 mg Capsules in Females Under Fasting Conditions

Phase 1

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Drug: Ribavirin 200 mg Oral Capsule (Geneva Pharmaceutical, U.S.A.); Drug: Rebetol 200 mg Oral Capsule (Schering Corporation, U.S.A.)

• Registration Number: NCT00960479
• 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 fasting conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-01
• Primary Completion: 2001-02
• Study Completion: 2001-02
• Status Verified: 2009-08
• Study First Submitted: 2009-08-13
• Study First Submitted QC: 2009-08-14
• Study First Posted: 2009-08-17
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

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
1	Ribavirin 200 mg Oral Capsule (Geneva Pharmaceutical, U.S.A.)	Ribavirin 200 mg Oral Capsule (Geneva Pharmaceutical, U.S.A.)
2	Rebetol 200 mg Oral Capsule (Schering Corporation, U.S.A.)	Rebetol 200 mg Oral Capsule (Schering Corporation, U.S.A.)

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	30 days