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

D. V. Reikhart; V. S. Arnautov; A. V. Belostotskii; A. A. Globenko; I. G. Lopukhov; E. V. Torshina

doi:10.1007/s11094-018-1722-8

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

Authors: Reikhart D.V.¹, Arnautov V.S.², Belostotskii A.V.¹, Globenko A.A.², Lopukhov I.G.², Torshina E.V.²
Affiliations:
1. I. M. Sechenov First Moscow State Medical University (Sechenov University), Ministry of Health of Russia
2. Valenta Pharm Company
Issue: Vol 51, No 11 (2018)
Pages: 954-959
Section: Article
URL: https://journals.rcsi.science/0091-150X/article/view/244870
DOI: https://doi.org/10.1007/s11094-018-1722-8
ID: 244870

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Abstract
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Abstract

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.

Keywords

teriflunomide, bioequivalence, pharmacokinetics, AUC, C_max, T_max, T_1/2

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

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Abstract

Keywords

About the authors

D. V. Reikhart

V. S. Arnautov

A. V. Belostotskii

A. A. Globenko

I. G. Lopukhov

E. V. Torshina

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