[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, double-crossover bioequivalence study of bisoprolol and amlodipine tablets in healthy volunteers under fasting conditions
主要研究目的 观察中国健康受试者空腹条件下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,新乡双鹭药业有限公司生产)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;持证商为Merck Kft.)后的药代动力学特点,评价两制剂的人体生物等效性。次要研究目的 观察受试制剂和参比制剂比索洛尔氨氯地平片在健康成年受试者中的安全性。
[Translation] Main study objectives: To observe the pharmacokinetic characteristics of the test preparation bisoprolol amlodipine tablets (specifications: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine), produced by Xinxiang Shuanglu Pharmaceutical Co., Ltd.) and the reference preparation bisoprolol amlodipine tablets (specifications: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine); the licensee is Merck Kft.) after oral administration under fasting conditions in healthy Chinese subjects, and to evaluate the human bioequivalence of the two preparations. Secondary study objectives: To observe the safety of the test preparation and the reference preparation bisoprolol amlodipine tablets in healthy adult subjects.