[Translation] Bioequivalence study of telmisartan tablets in humans under fasting and fed conditions
主要研究目的:考察健康受试者在空腹及餐后条件下,单次口服由西安迪赛生物药业有限责任公司生产的替米沙坦片(受试制剂,规格:80mg)与相同条件下单次口服由Boehringer Ingelheim公司持证的替米沙坦片(参比制剂,商品名:美卡素®,规格:80mg)的药动学特征,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:考察健康受试者在空腹及餐后条件下,单次口服由西安迪赛生物药业有限责任公司生产的替米沙坦片(受试制剂,规格:80mg)与相同条件下单次口服由Boehringer Ingelheim公司持证的替米沙坦片(参比制剂,商品名:美卡素®,规格:80mg)的安全性。
[Translation] The main purpose of the study is to investigate the pharmacokinetic characteristics of Telmisartan Tablets (test preparation, specification: 80 mg) produced by Xi'an Disai Biopharmaceutical Co., Ltd. and Telmisartan Tablets (reference preparation, trade name: Mikasu®, specification: 80 mg) certified by Boehringer Ingelheim under the same conditions after a single oral administration in healthy subjects under fasting and postprandial conditions, evaluate the bioequivalence between the two preparations, and provide a basis for the consistency evaluation of the test preparation.
Secondary purpose of the study is to investigate the safety of Telmisartan Tablets (test preparation, specification: 80 mg) produced by Xi'an Disai Biopharmaceutical Co., Ltd. and Telmisartan Tablets (reference preparation, trade name: Mikasu®, specification: 80 mg) certified by Boehringer Ingelheim under the same conditions after a single oral administration in healthy subjects under fasting and postprandial conditions.