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

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00960479
First received: August 13, 2009
Last updated: August 14, 2009
Last verified: August 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C
 Drug: Ribavirin 200 mg Oral Capsule (Geneva Pharmaceutical, U.S.A.)
Drug: Rebetol 200 mg Oral Capsule (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 Fasting Conditions.

Resource links provided by NLM:

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

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: 38
Study Start Date: January 2001
Study Completion Date: February 2001
Primary Completion Date: February 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Ribavirin 200 mg Oral Capsule (Geneva Pharmaceutical, U.S.A.)
 Drug: Ribavirin 200 mg Oral Capsule (Geneva Pharmaceutical, U.S.A.)
Active Comparator: 2
Rebetol 200 mg Oral Capsule (Schering Corporation, U.S.A.)
 Drug: Rebetol 200 mg Oral Capsule (Schering Corporation, U.S.A.)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00960479

Sponsors and Collaborators
Sandoz Inc.
Investigators
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.
ClinicalTrials.gov Identifier: NCT00960479     History of Changes
Other Study ID Numbers: P1BH00001
Study First Received: August 13, 2009
Last Updated: August 14, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013