clinical trial · NCT00834405
Leflunomide 20 mg Tablets, Non-Fasting
Teva Pharmaceuticals USA·phase1·completed·n = 37
HealthyARAVA® 20 mg tabletsLeflunomide 20 mg Tablets
brief 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.
started
Apr 1, 2002
primary completion
May 1, 2002
completion
May 1, 2002
last updated
Aug 19, 2024
detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
official title
A Relative Bioavailability, Parallel Study of Leflunomide 20 mg Tablets Under Non-Fasting Conditions
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol