Bioequivalence study of the medicinal products Flutrixan and Nexavar

А replicate designed open-label, randomized, crossover single-dose bioequivalence study using three periods and three sequences was conducted to assess the comparative bioavailability of the sorafenib-containing medicinal products Flutrixan (200 mg tablet, Institute of Bioorganic Chemistry of NAS of Belarus, Belarus) and Nexavar (200 mg tablet, Bayer Pharma AG, Germany), in healthy volunteers under fasting conditions. It was shown that all criteria used to assess the bioequivalence of compared medicinal products were fulfilled. The Test/Reference geometric mean ratios obtained for the pharmacokinetic parameters C_max and AUC_0-72 and the corresponding 90 % confidence intervals were within the acceptance range of 80.0-125.0 %. Both sorafenib products were well tolerated and had a favorable safety profile. Therefore, it can be concluded that the generic medicinal product Flutrixan is bioequivalent to the reference medicinal product Nexavar.

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