[Translation] Oral administration of telmisartan and amlodipine tablets on an empty stomach/after meals in healthy subjects, randomized, open, two preparations, three cycles, partially repeated, crossover bioequivalence study
主要目的:
考察中国健康受试者在空腹/餐后条件下单次口服替米沙坦氨氯地平片(规格:80mg/5mg)后体内药代动力学特征,评价江苏迪赛诺制药有限公司生产的替米沙坦氨氯地平片与持证商Boehringer Ingelheim International GmbH.的替米沙坦氨氯地平片的生物等效性。
次要目的:
评价单剂量口服替米沙坦氨氯地平片(规格:80mg/5mg)受试制剂及参比制剂在中国健康受试者中的安全性。
[Translation] main purpose:
To investigate the pharmacokinetic characteristics of Chinese healthy subjects after a single oral administration of Telmisartan Amlodipine Tablets (specification: 80mg/5mg) under fasting/fed conditions, and to evaluate the alternatives produced by Jiangsu Desano Pharmaceutical Co., Ltd. Bioequivalence of Misartan Amlodipine Tablets and Telmisartan Amlodipine Tablets from licensee Boehringer Ingelheim International GmbH.
Secondary purpose:
To evaluate the safety of single-dose oral telmisartan and amlodipine tablets (specification: 80mg/5mg) test preparation and reference preparation in Chinese healthy subjects.