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Leflunomide 20 mg Tablets Under Fasting Conditions

2014-08-27 03:24:40 | BioPortfolio

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.

Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label

Conditions

Healthy

Intervention

Leflunomide 20 mg Tablets, ARAVA™ 20 mg Tablets

Location

PRACS Institute, Ltd.
Fargo
North Dakota
United States
58104

Status

Completed

Source

Teva Pharmaceuticals USA

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:24:40-0400

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