NCT00834405

Leflunomide 20 mg Tablets, Non-Fasting

A Relative Bioavailability, Parallel Study of Leflunomide 20 mg Tablets Under Non-Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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

Conditions

• Healthy

Interventions

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

Timeline

• Start date: 2002-04-01
• Primary completion: 2002-05-01
• Completion: 2002-05-01
• First posted: 2009-02-03
• Last updated: 2024-08-19
• Results posted: 2009-08-18

Locations

2 sites across 1 country: United States