drugset / Trial / NCT00834418
Leflunomide 20 mg Tablets Under Fasting Conditions
RandomizedParallel-groupOpen-labelOther
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.
Timeline
- Start
- 2002-06
- Primary completion
- 2002-07
- Completion
- 2002-07
Outcome
Met primary endpoint
registry analysis (unspecified test); Leflunomide vs Arava™; Geometric Test/Ref Ratio x 100 107 (90% CI 99.6 to 116) NCT00834418 ↗
registry analysis (unspecified test); Leflunomide vs Arava™; Geometric Test/Ref Ratio x 100 102 (90% CI 95.2 to 109) NCT00834418 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Leflunomide | Small molecule | 20 mg | Oral |
Indications
No indication recorded.