Haikou Pharmaceutical Co. Ltd.

Primary objective: To use the vonoprazan fumarate tablets developed by Haikou Pharmaceutical Factory Co., Ltd. as the test preparation and the vonoprazan fumarate tablets (trade name: Walker) certified by Takeda Pharmaceutical Company Limited as the reference preparation, to investigate the pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial state, 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 administration in fasting/postprandial state in healthy Chinese subjects.

Linezolid tablets (specification: 600 mg) produced by Haikou Pharmaceutical Factory Co., Ltd. were used as the test preparation, and linezolid tablets (trade name: Zyvox®/Zyvox®, specification: 600 mg) produced by Pfizer Pharmaceuticals.LLC 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, and the safety of the two preparations in healthy subjects was evaluated.

Main study objectives To evaluate the pharmacokinetic characteristics and bioequivalence of the test preparation rosuvastatin capsules (specification: 50 mg, produced by Haikou Pharmaceutical Factory Co., Ltd.) and the reference preparation rosuvastatin capsules (trade name: Aerizol®, specification: 50 mg; licensee: FibroGen (China) Pharmaceutical Technology Development Co., Ltd.) in Chinese healthy subjects under fasting and postprandial conditions. Secondary study objectives To observe the safety of the test preparation rosuvastatin capsules and the reference preparation Aerizol® in healthy adult subjects.