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

Autor: A. V. Belostotskii, V. S. Arnautov, I. G. Lopukhov, E. V. Torshina, D. V. Reikhart, A. A. Globenko
Rok vydání: 2018
Předmět:
Zdroj: Pharmaceutical Chemistry Journal. 51:954-959
ISSN: 1573-9031
0091-150X
DOI: 10.1007/s11094-018-1722-8
Popis: 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.
Databáze: OpenAIRE
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