Comparison of Pharmacokinetics, Bioequivalence, and Safety of Femorix® (Valenta Pharm Company, Russia) and Aubagio® (Sanofi Winthrop Industrie, France) Film-Coated Tablets (14 mg)

Resumo

The pharmacokinetics, bioequivalence, and safety of Femorix^® (Valenta Pharm Co., Russia) and Aubagio^® (SanofiWinthrop Industrie, France) film-coated tablets (14 mg) were compared in a double-blind randomized investigation in parallel groups of healthy volunteers. The bioavailabilities of Femorix^® film-coated tablets (14 mg, Valenta Pharm Co., Russia) were 96.18% [87.92 – 105.22%] for ln(Cmax) and 96.24% [88.67 – 104.44%] for ln(AUC0–72) of those for Aubagio^® film-coated tablets (14 mg, Sanofi Winthrop Industrie, France), which fell in the commonly accepted range (80 – 125%) for proving the bioequivalence of the tested products.