[Translation] A randomized, open-label, two-dose, three-period, partially repeated, crossover bioequivalence study of telmisartan and amlodipine tablets in healthy volunteers after single oral administration on an empty stomach or after a meal
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] Primary objective:
To investigate the pharmacokinetic characteristics of Telmisartan Amlodipine Tablets (Specifications: 80mg/5mg) in Chinese healthy subjects after a single oral administration under fasting/postprandial conditions, and to evaluate the bioequivalence of Telmisartan Amlodipine Tablets produced by Jiangsu Desano Pharmaceutical Co., Ltd. and Telmisartan Amlodipine Tablets produced by Boehringer Ingelheim International GmbH.
Secondary objective:
To evaluate the safety of the test and reference formulations of Telmisartan Amlodipine Tablets (Specifications: 80mg/5mg) taken orally in Chinese healthy subjects.