[Translation] A randomized, open-label, single-dose, two-drug, two-period crossover design was used to evaluate the bioequivalence of the test formulation amlodipine besylate tablets (Chongqing Gisrui Pharmaceutical Co., Ltd.) and the reference formulation amlodipine besylate tablets (trade name: Norvasc, Pfizer Pharmaceuticals Co., Ltd.) in healthy Chinese subjects under fasting and fed conditions.
主要目的:以重庆药友制药有限责任公司生产、重庆吉斯瑞制药有限责任公司持证的苯磺酸氨氯地平片为受试制剂,以辉瑞制药有限公司生产的苯磺酸氨氯地平片(商品名:络活喜)为参比制剂,进行生物等效性试验,评价受试制剂和参比制剂是否生物等效。
次要目的:考察中国健康成年受试者空腹/餐后状态下口服试验药物的安全性。
[Translation] Main purpose: To conduct a bioequivalence test using amlodipine besylate tablets produced by Chongqing Yaoyou Pharmaceutical Co., Ltd. and licensed by Chongqing Jisrui Pharmaceutical Co., Ltd. as the test preparation and amlodipine besylate tablets (trade name: Norvasc) produced by Pfizer Pharmaceuticals Co., Ltd. as the reference preparation to evaluate whether the test preparation and the reference preparation are bioequivalent.
Secondary purpose: To investigate the safety of oral test drugs in fasting/postprandial state in healthy Chinese adult subjects.