At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 37 enrolled
Drug / intervention
ARAVA® 20 mg tablets +1 moredrug
Likely dose
ARAVA® 20 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, Parallel Study of Leflunomide 20 mg Tablets Under Non-Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating ARAVA® 20 mg tablets and Leflunomide 20 mg Tablets for Healthy. Completed, enrolled 37 participants across 2 sites.
Detailed Summary
The objective of this study is to compare the relative bioavailability of leflunomide 20 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of ARAVA 20 mg tablets (Aventis) in healthy, adult, non-smoking subjects \[females (who are unable to become pregnant) and vasectomized males\] under non-fasting conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2002
Primary CompletionMay 2002
First PostedFeb 2009
TodayJul 2026
First PostedFeb 3, 2009
Enrollment StartApr 1, 2002
Primary CompletionMay 1, 2002
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.4 years ago
Interventions
ARAVA® 20 mg tabletsdrug
1 x 20 mg, single-dose non-fasting
Leflunomide 20 mg Tabletsdrug
1 x 20 mg, single-dose non-fasting