[Translation] A single-center, randomized, open-label, two-dose, four-period, two-sequence, completely repeated crossover fasting and fed bioequivalence study of telmisartan tablets in healthy subjects
主要研究目的:以江苏省亚邦爱普森药业有限公司研制的替米沙坦片(规格:80 mg)为受试制剂,与Boehringer Ingelheim International GmbH持证的替米沙坦片(商品名:美卡素®/Micardis®,规格:80 mg)为参比制剂,研究受试制剂和参比制剂在空腹和高脂餐后条件下给药后的药代动力学参数,进行人体生物等效性评价。次要研究目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] The main purpose of the study was to use the Telmisartan Tablets (Specification: 80 mg) developed by Jiangsu Yabang Epson Pharmaceutical Co., Ltd. as the test preparation and the Telmisartan Tablets (trade name: Micardis®/Micardis®, Specification: 80 mg) certified by Boehringer Ingelheim International GmbH as the reference preparation to study the pharmacokinetic parameters of the test preparation and the reference preparation after administration under fasting and high-fat meal conditions, and to evaluate the bioequivalence in humans. The secondary purpose of the study was to observe the safety of the test preparation and the reference preparation in healthy subjects.