Zhejiang Jianfeng Pharmaceutical Co., Ltd.

Main purpose: This study used the tofacitinib citrate extended-release tablets (specification: 11 mg) produced and owned by Zhejiang Jianfeng Pharmaceutical Co., Ltd. as the test preparation. According to the relevant regulations of bioequivalence studies, the tofacitinib citrate extended-release tablets (specification: 11 mg, trade name: Shangjie®/Xeljanz®) produced by Pfizer Pharmaceuticals LLC were used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting/postprandial conditions. Secondary purpose: Observe the safety of the test preparation tofacitinib citrate extended-release tablets and the reference preparation tofacitinib citrate extended-release tablets (Shangjie®/Xeljanz®) in healthy subjects.

Main purpose: With healthy subjects as the test subjects, a randomized, open, two-period, two-sequence, double-crossover design was used to investigate the in vivo time course of mesartan after a single oral administration of mesartan potassium tablets (test preparation, specification: 80 mg) produced by Zhejiang Jianfeng Pharmaceutical Co., Ltd. and mesartan potassium tablets (reference preparation, trade name: Edabi®, specification: 80 mg) produced by Takeda Ireland Ltd. (licensed by Takeda Pharma A/S) to healthy subjects on an empty stomach and after a meal, estimate their relevant pharmacokinetic parameters and relative bioavailability, evaluate their bioequivalence in the fasting and after-meal state, and provide a basis for the production registration application of the test preparation. Secondary purpose: To evaluate the safety of the test preparation and reference preparation of mesartan potassium tablets (trade name: Edabi®) in healthy subjects.

The vonoprazan fumarate tablets (specification: 20 mg) developed by Zhejiang Jianfeng Pharmaceutical Co., Ltd. were used as the test preparation, and the vonoprazan fumarate tablets (trade name: Walker®/Vocinti®, specification: 20 mg) produced by Takeda Pharmaceutical Company Limited were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.