NCT00834418

Leflunomide 20 mg Tablets Under Fasting Conditions

A Relative Bioavailability Study of 20 mg Leflunomide Tablets Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Leflunomide 20 mg Tablets	1 x 20 mg, single-dose fasting
DRUG	ARAVA™ 20 mg Tablets	1 x 20 mg, single-dose fasting

Timeline

• Start date: 2002-06-01
• Primary completion: 2002-07-01
• Completion: 2002-07-01
• First posted: 2009-02-03
• Last updated: 2024-08-20
• Results posted: 2009-08-18

Locations

1 site across 1 country: United States