[Translation] A randomized, open-label, single-dose, two-period, self-crossover bioequivalence study of levamlodipine besylate tablets in healthy subjects under fasting and fed conditions
主要研究目的:以常州瑞明药业有限公司研发的苯磺酸左氨氯地平片(规格:5 mg)为受试制剂,按生物等效性研究的有关规定,与辉瑞制药有限公司生产的苯磺酸氨氯地平片(规格:10 mg,参比制剂,商品名:络活喜®)对比在健康人体内的相对生物利用度,考察两制剂的人体生物等效性。
次要研究目的:比较受试制剂苯磺酸左氨氯地平片和参比制剂苯磺酸氨氯地平片(商品名:络活喜®)在健康受试者中的安全性。
[Translation] Main research purpose: Using levamlodipine besylate tablets (specification: 5 mg) developed by Changzhou Ruiming Pharmaceutical Co., Ltd. as the test preparation, according to the relevant provisions of bioequivalence studies, the relative bioavailability of amlodipine besylate tablets (specification: 10 mg, reference preparation, trade name: Norvasc®) produced by Pfizer Pharmaceuticals Co., Ltd. was compared in healthy humans, and the human bioequivalence of the two preparations was investigated.
Secondary research purpose: To compare the safety of the test preparation levamlodipine besylate tablets and the reference preparation amlodipine besylate tablets (trade name: Norvasc®) in healthy subjects.