Shaanxi BAI LU Pharmaceutical Co. Ltd.

The main purpose of the study is to study the pharmacokinetics of the test preparation rosuvastatin ezetimibe tablets (I) (specification: 10mg/10mg, produced by Shaanxi Bailu Pharmaceutical Co., Ltd.) and the reference preparation rosuvastatin ezetimibe tablets (I) (trade name: Zhilida®/ZENON®; specification: 10mg/10mg; produced by Sanofi Ilac Sanayi ve Ticaret Anonim Sirketi) in healthy subjects after a single oral administration in the fasting/fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fasting/fed state. Secondary purpose of the study is to evaluate the safety of the test preparation rosuvastatin ezetimibe tablets (I) (specification: 10mg/10mg) and the reference preparation rosuvastatin ezetimibe tablets (I) (trade name: Zhilida®/ZENON®, specification: 10mg/10mg) in healthy subjects.

The main purpose of the study is to study the pharmacokinetics of the test preparation, Miasartan Potassium Tablets (Specification: 80 mg, produced by Shaanxi Bailu Pharmaceutical Co., Ltd.) and the reference preparation, Miasartan Potassium Tablets (trade name: Edabi®; Specification: 80 mg; produced by Takeda Ireland Ltd.) in healthy subjects after a single oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state. Secondary purpose of the study: to evaluate the safety of the test preparation, Miasartan Potassium Tablets (Specification: 80 mg) and the reference preparation, Edabi® (Specification: 80 mg) in healthy subjects.

Bisoprolol Amlodipine Tablets (specification: 5 mg/5 mg) produced by Shaanxi Bailu Pharmaceutical Co., Ltd. was used as the test preparation, and Bisoprolol Amlodipine Tablets (Kangxin'an®, specification: 5 mg/5 mg) produced by Merck Kft. and Egis Pharmaceuticals Plc was 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.