[Translation] A single-center, randomized, open-label, two-dose, three-period, three-sequence, crossover bioequivalence study of telmisartan capsule 40 mg in healthy Chinese volunteers after single oral administration on an empty stomach or after a meal
主要研究目的
评价中国健康受试者空腹及餐后条件下单次单剂量口服江西杏林白马药业股份有限公司提供的受试制剂替米沙坦胶囊(40 mg)与Boehringer Ingelheim International GmbH持证的参比制剂替米沙坦片(商品名:Micardis®,40 mg)的药动学特征,比较其相对生物利用度,评价两制剂间的生物等效性,为该受试制剂一致性评价提供依据。
次要研究目的
研究单次口服40mg的受试制剂替米沙坦胶囊或参比制剂替米沙坦片(商品名:Micardis®,40mg)在健康受试者中的安全性。
[Translation] Main study objectives
To evaluate the pharmacokinetic characteristics of the test preparation Telmisartan Capsules (40 mg) provided by Jiangxi Xinglin Baima Pharmaceutical Co., Ltd. and the reference preparation Telmisartan Tablets (trade name: Micardis®, 40 mg) certified by Boehringer Ingelheim International GmbH in Chinese healthy subjects under fasting and postprandial conditions, compare their relative bioavailability, evaluate the bioequivalence between the two preparations, and provide a basis for the consistency evaluation of the test preparation.
Secondary study objectives
To study the safety of a single oral administration of 40 mg of the test preparation Telmisartan Capsules or the reference preparation Telmisartan Tablets (trade name: Micardis®, 40 mg) in healthy subjects.