[Translation] Bisoprolol Amlodipine Tablets (specification: 5 mg/5 mg) produced by Zhejiang Huayuan Pharmaceutical Co., Ltd. is the same as Bisoprolol Amlodipine Tablets (Kang Xin'an) whose license holder is Merck Kft and the manufacturer is Egis Pharmaceuticals Plc. ®, 5 mg/5 mg), a single-center, randomized, open-label, two-formulation, two-cycle, single-dose, double-crossover, fasting and postprandial bioequivalence study in Chinese healthy subjects
以浙江花园药业有限公司生产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) produced by Zhejiang Huayuan Pharmaceutical Co., Ltd. were used as the test preparation. The license holder was Merck Kft and the manufacturer was Egis Pharmaceuticals Plc. Diping 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 under fasting and postprandial conditions were investigated to evaluate the two preparations. Whether it is bioequivalent. The safety and tolerability of both formulations in healthy humans were also evaluated.