Zhejiang Jiangbei Pharmaceutical Co. Ltd.

To investigate the pharmacokinetic characteristics of a single oral administration of bisoprolol amlodipine tablets [test preparation, specification: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine)] provided by Zhejiang Jiangbei Pharmaceutical Co., Ltd. in healthy subjects under fasting and postprandial conditions and a single oral administration of bisoprolol amlodipine tablets [reference preparation, specification: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine)] certified by Merck Kft under the same conditions, evaluate the bioequivalence and safety of the two preparations, and provide a basis for the registration application of the test preparation.

Ticagrelor tablets (90 mg) owned by Zhejiang Jiangbei Pharmaceutical Co., Ltd. was used as the test preparation, and BRILINTA® marketed by AstraZeneca AB 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.

Primary objective: To compare the differences in the degree and rate of absorption of atorvastatin calcium tablets (20 mg) provided by Zhejiang Jiangbei Pharmaceutical Co., Ltd. and atorvastatin calcium tablets (trade name: Lipitor®, specification: 20 mg) licensed by Pfizer Pharmaceuticals Co., Ltd. in healthy Chinese people under fasting and postprandial administration conditions using a single-center, randomized, open, two-dose, four-period completely repeated crossover, single-dose administration design. Secondary objective: To evaluate the safety of atorvastatin calcium tablets (specification: 20 mg) provided by Zhejiang Jiangbei Pharmaceutical Co., Ltd. and atorvastatin calcium tablets (trade name: Lipitor®, specification: 20 mg) licensed by Pfizer Pharmaceuticals Co., Ltd. under fasting and postprandial conditions.