Amlodipine Besylate/Bisoprolol Fumarate

Bisoprolol Amlodipine Tablets developed by Hunan Qianjin Xieli Pharmaceutical Co., Ltd. were used as the test preparation, and Bisoprolol Amlodipine Tablets (trade name: Kangxinan®) licensed by Merck Kft and produced by Egis Pharmaceuticals PLC were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration under fasting and postprandial conditions were investigated to evaluate whether the two preparations were bioequivalent.

"Main research purpose: According to the relevant provisions of bioequivalence test, Bisoprolol Amlodipine Tablets (trade name: Kangxinan, specification: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine)) produced by Merck Kft as the licensee was selected as the reference preparation, and the test preparation Bisoprolol Amlodipine Tablets (Specifications: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine)) produced and provided by Shandong Yikang Pharmaceutical Co., Ltd. was subjected to postprandial human bioequivalence test to compare the absorption rate and degree of the drug in the test preparation. Whether the difference with the reference preparation is within the acceptable range, evaluate the bioequivalence of the two preparations under postprandial administration conditions. Secondary study purpose: To observe the safety of the test preparation bisoprolol amlodipine tablets (specification: bisoprolol fumarate 5mg and amlodipine besylate (calculated as amlodipine) 5mg) and the reference preparation bisoprolol amlodipine tablets (trade name: Kangxinan, specification: bisoprolol fumarate 5mg and amlodipine besylate (calculated as amlodipine) 5mg) taken orally by healthy subjects. "