[Translation] A randomized, open-label, two-dose, single-dose, three-cycle postprandial, three-sequence, partially repeated crossover bioequivalence study of telmisartan tablets in Chinese healthy subjects
主要目的:以江苏长江药业有限公司生产、南京双科医药开发有限公司提供的替米沙坦片为受试制剂,按生物等效性研究的有关规定,与Boehringer Ingelheim Ellas A.E公司生产的替米沙坦片(商品名:Micardis®,参比制剂)对比在健康人体内的吸收速度及吸收程度,考察两制剂的人体生物等效性。
次要目的:观察受试制剂替米沙坦片和参比制剂替米沙坦片(Micardis® )在健康受试者中的安全性。
[Translation] Main purpose: Using telmisartan tablets produced by Jiangsu Changjiang Pharmaceutical Co., Ltd. and provided by Nanjing Shuangke Pharmaceutical Development Co., Ltd. as the test preparation, according to the relevant provisions of bioequivalence studies, the absorption rate and degree of telmisartan tablets (trade name: Micardis®, reference preparation) produced by Boehringer Ingelheim Ellas A.E. were compared in healthy humans to investigate the bioequivalence of the two preparations.
Secondary purpose: To observe the safety of the test preparation telmisartan tablets and the reference preparation telmisartan tablets (Micardis®) in healthy subjects.