At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 28 enrolled
Drug / intervention
Ribavirin 200 mg tablets +1 moredrug
Likely dose
Ribavirin 200 mg tabletsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Relative Bioavailability Study of Ribavirin 200 mg Tablets Under Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating Ribavirin 200 mg tablets and COPEGUS™ for Healthy. Completed, enrolled 28 participants across 2 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2003
Primary CompletionOct 2003
First PostedFeb 2009
TodayJul 2026
First PostedFeb 3, 2009
Enrollment StartSep 1, 2003
Primary CompletionOct 1, 2003
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.4 years ago
Interventions
Ribavirin 200 mg tabletsdrug
1 x 200 mg, single-dose fasting
COPEGUS™drug
1 x 200 mg, single-dose fasting