Ribavirin 200 mg Tablets Under Non-Fasting Conditions

A Relative Bioavailability Study of Ribavirin 200 mg Tablets Under Non-Fasting Conditions

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 non-fasting conditions.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Ribavirin 200 mg tablets; Drug: COPEGUS™ 200 mg Tablets

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77042
      • Novum Pharmaceutical Research Services
    • Houston, Texas, United States, 77099
      • Bioassay Laboratory, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Ribavirin 200 mg tablets; 1 x 200 mg, single-dose non-fasting
Active Comparator: 2	Drug: COPEGUS™ 200 mg Tablets; 1 x 200 mg, single-dose non-fasting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)	Bioequivalence based on Cmax.	Blood samples collected over a 72 hour period.
AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time of 72 Hours)	Bioequivalence based on AUC0-72.	Blood samples collected over a 72 hour period.

Collaborators and Investigators

• Sponsor: Teva Pharmaceuticals USA

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (Actual): October 1, 2003
• Study Completion (Actual): October 1, 2003

Study Registration Dates

• First Submitted: January 30, 2009
• First Submitted That Met QC Criteria: February 2, 2009
• First Posted (Estimate): February 3, 2009

Study Record Updates

• Last Update Posted (Estimate): September 11, 2009
• Last Update Submitted That Met QC Criteria: September 1, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Bioequivalence; Healthy Subjects
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Ribavirin
• Other Study ID Numbers: B036553