[Translation] A randomized, open-label, single-dose, 2-sequence, 4-period, crossover, fasting and fed bioequivalence study of telmisartan hydrochlorothiazide tablets (80 mg/12.5 mg) developed by Nanjing Huanglong Biotechnology Co., Ltd. and telmisartan hydrochlorothiazide tablets (Mekasu®, 80 mg/12.5 mg) marketed by Boehringer Ingelheim International GmbH in healthy Chinese subjects
以南京黄龙生物科技有限公司研制的替米沙坦氢氯噻嗪片(规格:80mg/12.5mg)为受试制剂,以Boehringer Ingelheim International GmbH公司上市的替米沙坦氢氯噻嗪片(美嘉素 ®,规格:80mg/12.5mg)为参比制剂,考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性;同时评价两种制剂在健康人体中的安全性和耐受性。
[Translation] Telmisartan hydrochlorothiazide tablets (specification: 80mg/12.5mg) developed by Nanjing Huanglong Biotechnology Co., Ltd. were used as the test preparation, and Telmisartan hydrochlorothiazide tablets (Mekasu ®, specification: 80mg/12.5mg) marketed by Boehringer Ingelheim International GmbH were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent; at the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.