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

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ClinicalTrials.gov Identifier: NCT00959933
Recruitment Status : Completed
First Posted : August 17, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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.
Study Start Date : April 2001
Actual Primary Completion Date : May 2001
Actual Study Completion Date : May 2001

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin
U.S. FDA Resources

Arm Intervention/treatment
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.)



Primary Outcome Measures :
  1. Bioequivalence based on AUC and Cmax [ Time Frame: 30 days ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00959933


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

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00959933     History of Changes
Other Study ID Numbers: P1BH01001
First Posted: August 17, 2009    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: August 2009

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents