Pharmacokinetic Bioequivalence Study of Two Formulations of Teriflunomide in Healthy Male Volunteers under Fasting Conditions

Abstract

A generic formula containing 14 mg of teriflunomide (Terflimida® test formulation) in oral coated tablets was compared to the reference product (Aubagio®) in a pharmacokinetic, open label, two-periods, two sequences, two-way crossover; block randomized single dose study in healthy male volunteers under fasting conditions.The statistical analysis of the pharmacokinetic data obtained in this study showed that the Teriflunomide formulations: Terflimida® coated tablets 14 (test formulation) and Aubagio® 14 mg coated tablets (reference formulation), were bioequivalent regarding the rate (Cmax) and the extent of absorption (AUC0-72), under fasting conditions. The Teriflunomide treatments (TEST and REFERENCE formulations), administered orally in single dose, to male healthy volunteers, under fasting conditions, were very well tolerated by all the participating subjects.