Shang Hai Heng Shan Yao Ye You Xian Gong Si

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

1. Primary study objective: To evaluate the bioequivalence of the two preparations in humans through a single-center, randomized, open, single-dose, two-cycle, double-crossover clinical study using AstraZeneca AB's licensed dapagliflozin tablets (trade name: Andatang) as the reference preparation and dapagliflozin tablets developed by Shanghai Hengshan Pharmaceutical Co., Ltd. as the test preparation. 2. Secondary study objective: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Main research purpose: According to the relevant provisions of bioequivalence test, Bisoprolol fumarate tablets (trade name: Kangxin; specification: 5mg) with Merck Serono GmbH as the licensee were selected as the reference preparation, and the test preparation Bisoprolol fumarate tablets (specification: 5mg) produced by Shanghai Hengshan Pharmaceutical Co., Ltd. and provided by Jinan Liangfu Jinghe Pharmaceutical Technology Co., Ltd. were subjected to human bioequivalence test for fasting and postprandial administration, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to compare the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary research purpose: To observe the safety of oral administration of the test preparation Bisoprolol fumarate tablets (specification: 5mg) and the reference preparation Bisoprolol fumarate tablets (trade name: Kangxin, specification: 5mg) by healthy subjects.