Shijiazhuang Puli Pharmaceutical Co Ltd.

Primary objective: To use the vonoprazan fumarate tablets developed by Shijiazhuang Puli Pharmaceutical Co., Ltd. as the test preparation and the vonoprazan fumarate tablets (trade name: Walker®) licensed by Takeda Pharmaceutical Company Limited as the reference preparation, to investigate the pharmacokinetic parameters and relative bioavailability of the two preparations in the fasting and postprandial state after a single dose, and to evaluate whether the two preparations are bioequivalent. Secondary objective: To evaluate the safety of the test and reference preparations of vonoprazan fumarate tablets after a single oral dose in the fasting/postprandial state in the participants of the China Health Study.

Pioglitazone metformin tablets (specification: 15 mg/500 mg) developed by Shijiazhuang Puli Pharmaceutical Co., Ltd. were used as the test preparation, and pioglitazone metformin tablets (trade name: Metact LD®, specification: 15 mg/500 mg) from Takeda Teba Pharmaceutical Co., Ltd. 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.

A randomized, open, single-dose, two-period, double-crossover bioequivalence study was conducted in healthy Chinese subjects on bisoprolol amlodipine tablets (specification: 5mg/5mg) produced by Shijiazhuang Puli Pharmaceutical Co., Ltd. and bisoprolol amlodipine tablets (specification: 5mg/5mg) whose licensee is Merck Kft and manufacturer is Egis Pharmaceuticals PLC under fasting and fed conditions.