Comparison of Pharmacokinetics, Bioequivalence, and Safety of Femorix<sup>®</sup>(Valenta Pharm Company, Russia) and Aubagio<sup>®</sup>(Sanofi Winthrop Industrie, France) Film-Coated Tablets (14 mg)
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01.02.2018 |
Reikhart D.
Arnautov V.
Belostotskii A.
Globenko A.
Lopukhov I.
Torshina E.
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Pharmaceutical Chemistry Journal |
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Ссылка
© 2018, Springer Science+Business Media, LLC, part of Springer Nature. 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.
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