At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 84 enrolled
Drug / intervention
Leflunomide 20 mg Tablets +1 moredrug
Likely dose
Leflunomide 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 Study of 20 mg Leflunomide Tablets Under Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating Leflunomide 20 mg Tablets and ARAVA™ 20 mg Tablets for Healthy. Completed, enrolled 84 participants across 1 site.
Detailed Summary
This study will compare the relative bioavailability (rate and extent of absorption) of 20 mg Leflunomide Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 20 mg ARAVA™ Tablets by Aventis Pharmaceuticals, Inc. following a single oral dose (1 x 20 mg tablet) in healthy adult subjects under fasting conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2002
Primary CompletionJul 2002
First PostedFeb 2009
TodayJul 2026
First PostedFeb 3, 2009
Enrollment StartJun 1, 2002
Primary CompletionJul 1, 2002
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.4 years ago
Interventions
Leflunomide 20 mg Tabletsdrug
1 x 20 mg, single-dose fasting
ARAVA™ 20 mg Tabletsdrug
1 x 20 mg, single-dose fasting