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

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Ribavirin 200 Capsules (Geneva Pharmaceutical, U.S.A.)
Rebetol 200 Capsules (Schering Corporation, U.S.A.)
Sponsored by
Sandoz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Ribavirin 200 Capsules (Geneva Pharmaceutical, U.S.A.)

    Rebetol 200 Capsules (Schering Corporation, U.S.A.)

    Outcomes

    Primary Outcome Measures

    Bioequivalence based on AUC and Cmax

    Secondary Outcome Measures

    Full Information

    First Posted
    August 13, 2009
    Last Updated
    March 27, 2017
    Sponsor
    Sandoz
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00959933
    Brief Title
    Relative Bioavailability Study of Ribavirin 200 Capsules and Rebetol 200 mg Capsules in Females Under Non-Fasting Conditions
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2001 (undefined)
    Primary Completion Date
    May 2001 (Actual)
    Study Completion Date
    May 2001 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sandoz

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Hepatitis C

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Ribavirin 200 Capsules (Geneva Pharmaceutical, U.S.A.)
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Rebetol 200 Capsules (Schering Corporation, U.S.A.)
    Intervention Type
    Drug
    Intervention Name(s)
    Ribavirin 200 Capsules (Geneva Pharmaceutical, U.S.A.)
    Intervention Type
    Drug
    Intervention Name(s)
    Rebetol 200 Capsules (Schering Corporation, U.S.A.)
    Primary Outcome Measure Information:
    Title
    Bioequivalence based on AUC and Cmax
    Time Frame
    30 days

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Piyush Patel, M.D.
    Organizational Affiliation
    Allied Clinical Research
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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