[Translation] Bisoprolol Amlodipine Tablets (specification: 5 mg/5 mg) developed by Dongyang Xiangsheng Pharmaceutical Technology Co., Ltd. is the same as Bisoprolol Amlodipine Tablets (Kangxin) whose license holder is Merck Kft and the manufacturer is Egis Pharmaceuticals Plc. Randomized, open-label, single-dose, two-cycle, double-crossover, fasting and postprandial bioequivalence study in Chinese healthy subjects
以东阳祥昇医药科技有限公司研制的比索洛尔氨氯地平片(规格:5 mg/5 mg)为受试制剂,以持证商为Merck Kft,生产商为Egis Pharmaceuticals Plc的比索洛尔氨氯地平片(康忻安®,规格:5 mg/5 mg)为参比制剂,考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性;同时评价两种制剂在健康人体中的安全性和耐受性。
[Translation] Bisoprolol amlodipine tablets (specification: 5 mg/5 mg) developed by Dongyang Xiangsheng Pharmaceutical Technology Co., Ltd. were used as the test preparation, and the license holder was Merck Kft and the manufacturer was Egis Pharmaceuticals Plc. Clodipine tablets (Kangxinan®, specification: 5 mg/5 mg) are used as reference preparations. The pharmacokinetic parameters and relative bioavailability of single administration of the two preparations in the fasting and postprandial states are investigated, and the two preparations are evaluated. Whether the preparations are bioequivalent; simultaneously evaluate the safety and tolerability of the two preparations in healthy humans.