Shanghai Sine Pharmaceutical Co. Ltd.

Using iriperazole tablets (2 mg) developed by Shandong Xinyi Pharmaceutical Co., Ltd. as the test formulation and iriperazole tablets (Rexulti®, 2 mg) certified by Otsuka Pharmaceutical Co., Ltd. as the reference formulation, the pharmacokinetic parameters and relative bioavailability of the two formulations after a single dose in a postprandial state were investigated to evaluate their bioequivalence. The safety of both formulations in healthy subjects was also evaluated.

Primary Objective: This study used budesonide enteric-coated capsules (4 mg) manufactured and owned by Tianjin Xinyi Jinjin Pharmaceutical Co., Ltd. as the test formulation, and budesonide enteric-coated capsules (4 mg, trade name: NEFECON®) owned by Everest Medicines (Singapore) Pte. Ltd. as the reference formulation, in accordance with relevant regulations for bioequivalence studies, to evaluate the bioequivalence of the test and reference formulations after administration under postprandial conditions. Secondary Objective: To observe the safety of the test and reference formulations, budesonide enteric-coated capsules (NEFECON®), in healthy trial participants.

Primary objective: To investigate the pharmacokinetic characteristics of the test formulation zolpidem tartrate extended-release tablets (12.5 mg, manufactured by Shandong Xinyi Pharmaceutical Co., Ltd.) and the reference formulation zolpidem tartrate extended-release tablets (trade name: AMBIEN CR®, 12.5 mg, SANOFI AVENTIS certified) after a single oral administration in Chinese healthy participants under fasting conditions, and to evaluate the bioequivalence of the two formulations. Secondary objective: To evaluate the safety of the test and reference formulations of zolpidem tartrate extended-release tablets after a single oral administration in Chinese healthy participants.