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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)


  • Reikhart D.
  • Arnautov V.
  • Belostotskii A.
  • Globenko A.
  • Lopukhov I.
  • Torshina E.
Дата публикации:01.02.2018
Журнал: Pharmaceutical Chemistry Journal
БД: Scopus
Ссылка: Scopus

Аннтотация

© 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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