[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, double-crossover bioequivalence study of bisoprolol-amlodipine tablets in Chinese healthy volunteers after fasting and feeding
主要研究目的
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,宁波大红鹰药业股份有限公司生产,宏越科技(湖州)有限公司提供)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,持证商:Merck Kft)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。
次要研究目的
评价健康受试者空腹和餐后单次口服受试制剂(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后的安全性。
[Translation] Main study objectives
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 Ningbo Dahongying Pharmaceutical Co., Ltd. and provided by Hongyue Technology (Huzhou) Co., Ltd.) and the reference preparation bisoprolol amlodipine tablets (specifications: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine), licensed by Merck Kft) 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 study objectives
To evaluate the safety of the test preparation (T) bisoprolol amlodipine tablets and the reference preparation (R) bisoprolol amlodipine tablets after a single oral administration in healthy subjects after a fasting and fed state.