[Translation] A randomized, open-label, two-way trial of amlodipine besylate granules (amlodipine, 10mg) and Norvasc® (amlodipine, 10mg) in Chinese healthy male and female subjects in the postprandial state. Formulation, single-dose, two-period, two-crossover bioequivalence studies
主要研究目的
以广东东阳光药业股份有限公司提供的苯磺酸氨氯地平颗粒(10mg)为受试制剂,按有关生物等效性试验的规定,与辉瑞制药有限公司(持证商)的苯磺酸氨氯地平片(商品名:络活喜®,10mg,参比制剂)进行人体相对生物利用度研究,评价餐后状态下单次口服受试制剂与参比制剂的生物等效性。
次要研究目的
评价中国健康男性和女性受试者餐后状态下单次口服苯磺酸氨氯地平颗粒受试制剂和参比制剂后的安全性。
[Translation] Main research purpose
Using amlodipine besylate granules (10 mg) provided by Guangdong HEC Pharmaceutical Co., Ltd. as the test preparation, according to the relevant bioequivalence test regulations, and Pfizer Pharmaceutical Co., Ltd. (certificate holder) besylate Amlodipine Tablets (trade name: Norvasc®, 10mg, reference preparation) was studied on the relative bioavailability of human body to evaluate the bioequivalence of the test preparation and the reference preparation after a single oral administration in the postprandial state.
Secondary research purpose
To evaluate the safety of Chinese healthy male and female subjects after a single oral administration of amlodipine besylate granule test preparation and reference preparation.