Shanghai Pukang Pharmaceutical Co. Ltd.

Healthy Chinese subjects were used as test subjects. A self-crossover design was used to determine the time course of rivaroxaban plasma concentration in healthy subjects after administration of rivaroxaban tablets developed by Shanghai Pukang Pharmaceutical Co., Ltd., and to estimate the corresponding pharmacokinetic parameters. Rivaroxaban tablets [trade name: Xarelto®] produced by Bayer Pharma AG were used as reference to investigate the bioavailability of the test preparation, evaluate the bioequivalence between preparations, and observe the safety of rivaroxaban tablets in healthy Chinese subjects.

Healthy Chinese subjects were used as test subjects. A self-crossover control trial design was adopted to determine the time course of blood drug concentration of rivaroxaban tablets developed by Shanghai Pukang Pharmaceutical Co., Ltd. in healthy subjects, and to estimate the corresponding pharmacokinetic parameters. Rivaroxaban tablets [trade name: Xarelto®] produced by Bayer AG were used as reference to evaluate the bioequivalence between the preparations and observe the safety of rivaroxaban tablets in healthy Chinese subjects.

The main purpose of the study is to use the metformin hydrochloride sustained-release tablets produced by the original research company Bristol-Myers Squibb Company as the reference preparation and the metformin hydrochloride sustained-release tablets produced by Shanghai Pukang Pharmaceutical Co., Ltd. as the test preparation to evaluate the human bioequivalence of the two preparations through a single-center, randomized, open, single-dose, two-cycle, double-crossover clinical study. Secondary purpose of the study: to observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.