[Translation] A single-center, randomized, open-label, fasting and fed, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of levamlodipine besylate tablets in healthy Chinese adult subjects
主要研究目的:
考察单次(空腹/餐后)口服2.5mg受试制剂苯磺酸左氨氯地平片(规格:2.5mg/片,以左氨氯地平计;四川新斯顿制药股份有限公司生产)与口服5mg参比制剂苯磺酸氨氯地平片(商品名:络活喜®;规格:5mg/片,以氨氯地平计;辉瑞制药有限公司生产),在中国健康人体的相对生物利用度,分析两种制剂的药代动力学参数,评价两制剂的生物等效性,为该药的申报及临床用药提供参考依据。
次要研究目的:
评价单次(空腹/餐后)口服2.5mg受试制剂苯磺酸左氨氯地平片与口服5mg参比制剂苯磺酸氨氯地平片在中国健康成年受试者中的安全性。
[Translation] Main research objectives:
To investigate the relative bioavailability of a single (fasting/postprandial) oral administration of 2.5 mg of the test preparation levamlodipine besylate tablets (specification: 2.5 mg/tablet, calculated as levamlodipine; produced by Sichuan Xinston Pharmaceutical Co., Ltd.) and 5 mg of the reference preparation levamlodipine besylate tablets (trade name: Norvasc®; specification: 5 mg/tablet, calculated as amlodipine; produced by Pfizer Pharmaceuticals Co., Ltd.) in healthy Chinese subjects, analyze the pharmacokinetic parameters of the two preparations, evaluate the bioequivalence of the two preparations, and provide a reference basis for the application and clinical use of the drug.
Secondary research objectives:
To evaluate the safety of a single (fasting/postprandial) oral administration of 2.5 mg of the test preparation levamlodipine besylate tablets and 5 mg of the reference preparation levamlodipine besylate tablets in healthy Chinese adult subjects.