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

Information source: Sandoz
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Hepatitis C

Intervention: Ribavirin 200 Capsules (Geneva Pharmaceutical, U.S.A.) (Drug); Rebetol 200 Capsules (Schering Corporation, U.S.A.) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Sandoz Inc.

Official(s) and/or principal investigator(s):
Piyush Patel, M.D., Principal Investigator, Affiliation: Allied Clinical Research

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.

Clinical Details

Official title: A Relative Bioavailability Study of Ribavirin (Geneva Pharmaceutical Technology Corporation, N.J., U.S.A.) 200 Capsules and Rebetol (Schering Corporation, N.J., U.S.A.) 200 mg Capsules in Females Under Non-Fasting Conditions.

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Bioequivalence based on AUC and Cmax

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Female.

Criteria:

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.

Locations and Contacts

Additional Information

Starting date: April 2001
Last updated: August 14, 2009

Page last updated: August 23, 2015

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