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

This study has been completed.
Information provided by:
Sandoz Identifier:
First received: August 13, 2009
Last updated: August 14, 2009
Last verified: August 2009

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.

Condition Intervention Phase
Chronic Hepatitis C
Drug: Ribavirin 200 Capsules (Geneva Pharmaceutical, U.S.A.)
Drug: Rebetol 200 Capsules (Schering Corporation, U.S.A.)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: April 2001
Study Completion Date: May 2001
Primary Completion Date: May 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Ribavirin 200 Capsules (Geneva Pharmaceutical, U.S.A.)
Drug: Ribavirin 200 Capsules (Geneva Pharmaceutical, U.S.A.)
Active Comparator: 2
Rebetol 200 Capsules (Schering Corporation, U.S.A.)
Drug: Rebetol 200 Capsules (Schering Corporation, U.S.A.)


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00959933

Sponsors and Collaborators
Sandoz Inc.
Principal Investigator: Piyush Patel, M.D. Allied Clinical Research
  More Information

No publications provided

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc. Identifier: NCT00959933     History of Changes
Other Study ID Numbers: P1BH01001
Study First Received: August 13, 2009
Last Updated: August 14, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anti-Infective Agents
Antiviral Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on March 03, 2015