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

被引：0

作者：

D. V. Reikhart

V. S. Arnautov

A. V. Belostotskii

A. A. Globenko

I. G. Lopukhov

E. V. Torshina

机构：

[1] I. M. Sechenov First Moscow State Medical University (Sechenov University),

[2] Ministry of Health of Russia,undefined

[3] Valenta Pharm Company,undefined

来源：

Pharmaceutical Chemistry Journal | 2018年 / 51卷

关键词：

teriflunomide; bioequivalence; pharmacokinetics;

D O I：

暂无

中图分类号：

学科分类号：

摘要：

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.

引用

页码：954 / 959

页数：5