Amlodipine Besylate/Bisoprolol Fumarate

A single-center, randomized, open, single-dose, two-period, self-crossover design was used to evaluate the pharmacokinetic parameters of bisoprolol amlodipine tablets (specifications: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine)) produced by Sinopharm Rongsheng Pharmaceutical Co., Ltd. and bisoprolol amlodipine tablets (trade name: Kangxinan®, specifications: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine)) certified by Merck Kft. The bioequivalence of the reference preparation and the test preparation in humans under fasting and fed conditions was evaluated.

"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. "