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

Sandoz

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis C

Treatments: Drug: Ribavirin 200 mg Oral Capsule (Geneva Pharmaceutical, U.S.A.); Drug: Rebetol 200 mg Oral Capsule (Schering Corporation, U.S.A.)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00960479

P1BH00001

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

1

Experimental group

Description:

Ribavirin 200 mg Oral Capsule (Geneva Pharmaceutical, U.S.A.)

Treatment:

Drug: Ribavirin 200 mg Oral Capsule (Geneva Pharmaceutical, U.S.A.)

2

Active Comparator group

Description:

Rebetol 200 mg Oral Capsule (Schering Corporation, U.S.A.)

Treatment:

Drug: Rebetol 200 mg Oral Capsule (Schering Corporation, U.S.A.)