Nanjing Hicin Pharmaceutical Co., Ltd.

Acipimox capsules (specification: 0.25 g) developed by Nanjing Haichen Pharmaceutical Co., Ltd. were used as the test preparation, and acipimox capsules (trade name: Olbetam, specification: 0.25 g) certified by Pfizer Italia were used as the reference preparation. The pharmacokinetic parameters of the test preparation and the reference preparation after administration under fasting and high-fat meal conditions were studied, and the human bioequivalence evaluation was performed.

Rivaroxaban tablets (specification: 2.5 mg) developed and produced by Nanjing Haichen Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant provisions of the bioequivalence test, the relative bioavailability of the two preparations in healthy humans was compared with the reference preparation (trade name: Xarelto®, specification: 2.5 mg) licensed by Bayer AG as the reference preparation. The safety of the test preparation of rivaroxaban tablets and the reference preparation (Xarelto®) in healthy subjects was observed.

Methods: Using voglibose tablets (Bexin®, 0.2 mg) produced by Tianjin Takeda Pharmaceutical Co., Ltd. as the reference preparation and voglibose tablets (0.2 mg) produced by Nanjing Haichen Pharmaceutical Co., Ltd. as the test preparation, a single-center, randomized, open, two-period double-crossover clinical trial was designed to evaluate the pharmacodynamics of the test preparation and the reference preparation after a single fasting oral administration in healthy subjects, so as to evaluate the bioequivalence of the two preparations under fasting conditions.