[Translation] Single-center, randomized, open-label, single-dose, two-sequence, two-period, double-crossover, fasting and fed states bioequivalence study of bisoprolol amlodipine tablets in healthy subjects
主要研究目的:以北京金城泰尔制药有限公司生产的比索洛尔氨氯地平片为受试制剂,以Merck Kft持证的比索洛尔氨氯地平片(康忻安®)为参比制剂,通过单中心、随机、开放、单剂量、两序列、两周期、双交叉、空腹和餐后状态下的临床研究来评价两种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在中国健康受试者中的安全性。
[Translation] The main research purpose: Bisoprolol amlodipine tablets produced by Beijing Jincheng Taier Pharmaceutical Co., Ltd. was used as the test preparation, and Bisoprolol amlodipine tablets (Kangxinan®) licensed by Merck Kft was used as the reference preparation. The human bioequivalence of the two preparations was evaluated by single-center, randomized, open-label, single-dose, two-sequence, two-period, double-crossover, fasting and postprandial clinical studies. Secondary research purpose: To observe the safety of the test preparation and the reference preparation in Chinese healthy subjects.