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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.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00959933
First received: August 13, 2009
Last updated: August 14, 2009
Last verified: August 2009

August 13, 2009
August 14, 2009
April 2001
May 2001   (final data collection date for primary outcome measure)
Bioequivalence based on AUC and Cmax [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00959933 on ClinicalTrials.gov Archive Site
Not Provided
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Relative Bioavailability Study of Ribavirin 200 Capsules and Rebetol 200 mg Capsules in Females Under Non-Fasting Conditions
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.

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis C
  • Drug: Ribavirin 200 Capsules (Geneva Pharmaceutical, U.S.A.)
  • Drug: Rebetol 200 Capsules (Schering Corporation, U.S.A.)
  • Experimental: 1
    Ribavirin 200 Capsules (Geneva Pharmaceutical, U.S.A.)
    Intervention: Drug: Ribavirin 200 Capsules (Geneva Pharmaceutical, U.S.A.)
  • Active Comparator: 2
    Rebetol 200 Capsules (Schering Corporation, U.S.A.)
    Intervention: Drug: Rebetol 200 Capsules (Schering Corporation, U.S.A.)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
May 2001
May 2001   (final data collection date for primary outcome measure)

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.
Female
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00959933
P1BH01001
Not Provided
Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Sandoz Inc.
Not Provided
Principal Investigator: Piyush Patel, M.D. Allied Clinical Research
Sandoz
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP