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Ribavirin 200 mg Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00835146
First Posted: February 3, 2009
Last Update Posted: September 11, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Teva Pharmaceuticals USA
  Purpose
The objective of this study is to compare the relative bioavailability of ribavirin 200 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of COPEGUS™ 200 mg tablets (Roche) in healthy, adult, non-smoking, females (who are unable to become pregnant) under fasting conditions.

Condition Intervention Phase
Healthy Drug: Ribavirin 200 mg tablets Drug: COPEGUS™ Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Relative Bioavailability Study of Ribavirin 200 mg Tablets Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax (Maximum Observed Concentration of Drug Substance in Plasma) [ Time Frame: Blood samples collected over a 72 hour period. ]
  • AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time of 72 Hours) [ Time Frame: Blood samples collected over a 72 hour period. ]

Enrollment: 28
Study Start Date: September 2003
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Ribavirin 200 mg tablets
1 x 200 mg, single-dose fasting
Active Comparator: 2 Drug: COPEGUS™
1 x 200 mg, single-dose fasting

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All subjects selected for this study will be non-smokers, at least 18 years of age, and a female whi is physically unable to become pregnant (postmenopausal for at least 6 months or surgically sterile). Subjects will have a BMI (body mass index) of 30 or less.
  • Each subject shall be given a general physical examination within 28 days of initiation of the study. Such examination includes but is not limited to, blood pressure, general observations, and history.
  • Each subject will be given a serum pregnancy test as part of the pre-study screening process.
  • Adequate blood and urine samples should be obtained within 28 days before beginning of the first period and at the end of the trial for clinical laboratory measurements.
  • Clinical laboratory measurements will include the following:

    • Hematology: hemoglobin, hematocrit, red blood cell count, platelets, and white blood cell count with differential.
    • Clinical Chemistry: creatinine, BUN, glucose, SGOT/AST, SGPT/ALT, bilirubin, and alkaline phosphatase.
    • Urine Analysis: pH, specific gravity, protein, glucose, ketones, bilirubin, occult blood, and cells.
    • HIV Screen: pre-study only
    • Hepatitis-B, C Screen: pre-study only
    • Drugs of Abuse Screen: (pre-study and at each check-in)
  • Subjects will be selected if all above are normal.

Exclusion Criteria:

  • Subjects with a significant recent history of chronic alcohol consumption (past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma (past 5 years), diabetes, psychosis or glaucoma will not be eligible for this study.
  • Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be retested. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator dems the result to not be significant.
  • Subjects who have a history of allergic responses to the class of drug being tested will be excluded from the study.
  • Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is required.
  • All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each dosing period check-in. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.
  • Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study.
  • Subjects who have taken any investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate.
  • Female subjects who are pregnant or who are able (women with child bearing potential) to become pregnant during the study will not be allowed to participate.
  • All female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or inconclusive results will be withdrawn from the study.
  • Subjects who do not tolerate venipuncture will not be allowed to participate.
  Contacts and Locations
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): NCT00835146


Locations
United States, Texas
Novum Pharmaceutical Research Services
Houston, Texas, United States, 77042
Bioassay Laboratory, Inc.
Houston, Texas, United States, 77099
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: So Ran Hong, M.D. Novum Pharmaceutical Research Services
  More Information

ClinicalTrials.gov Identifier: NCT00835146     History of Changes
Other Study ID Numbers: B036552
First Submitted: January 30, 2009
First Posted: February 3, 2009
Results First Submitted: July 2, 2009
Results First Posted: August 18, 2009
Last Update Posted: September 11, 2009
Last Verified: September 2009

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents