[Translation] A single-center, randomized, open-label, two-dose, two-period, two-sequence, double-crossover bioequivalence study of bisoprolol-amlodipine tablets in healthy subjects in the fasting and fed state
主要目的:研究空腹和餐后状态下单次口服受试制剂比索洛尔氨氯地平片(规格:富马酸比索洛尔5mg与苯磺酸氨氯地平(按氨氯地平计)5mg),苏州弘森药业股份有限公司生产)与参比制剂比索洛尔氨氯地平片(规格:富马酸比索洛尔5mg与苯磺酸氨氯地平(按氨氯地平计)5mg,Egis Pharmaceuticals PLC生产)在健康成年受试者体内的药代动力学,评价两制剂生物等效性。
次要目的:评价健康受试者空腹和餐后状态下单次口服受试制剂(T)比索洛尔氨氯地平片和参比制剂(R)比索洛尔氨氯地平片(康忻安®)后的安全性。
[Translation] Primary objective: To study the pharmacokinetics of the test preparation bisoprolol amlodipine tablets (specifications: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine), produced by Suzhou Hongsen Pharmaceutical Co., Ltd.) and the reference preparation bisoprolol amlodipine tablets (specifications: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine), produced by Egis Pharmaceuticals PLC) in healthy adult subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations.
Secondary objective: To evaluate the safety of the test preparation (T) bisoprolol amlodipine tablets and the reference preparation (R) bisoprolol amlodipine tablets (Kangxinan®) in healthy subjects after a single oral administration in the fasting and fed state.