[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of candesartan cilexetil and hydrochlorothiazide tablets (II) in healthy Chinese subjects under fasting and fed administration conditions.
主要目的:以药代动力学参数为终点指标,比较空腹和高脂餐后给药条件下,合肥合源药业有限公司生产的坎地沙坦酯氢氯噻嗪片(Ⅱ)与CHEPLAPHARM Arzneimittel GmbH持证的坎地沙坦酯氢氯噻嗪片(Ⅱ)在健康成年人群中吸收程度和速度的差异,对两制剂的生物等效性进行评价。次要目的:评价健康受试者在空腹和高脂餐后给药条件下口服受试制剂坎地沙坦酯氢氯噻嗪片(Ⅱ)和参比制剂坎地沙坦酯氢氯噻嗪片(Ⅱ)的安全性。
[Translation] Primary objective: To compare the differences in the extent and rate of absorption of candesartan cilexetil hydrochlorothiazide tablets (Ⅱ) produced by Hefei Heyuan Pharmaceutical Co., Ltd. and candesartan cilexetil hydrochlorothiazide tablets (Ⅱ) certified by CHEPHAPHARM Arzneimittel GmbH in healthy adults under fasting and high-fat meal administration conditions using pharmacokinetic parameters as endpoints, and to evaluate the bioequivalence of the two preparations. Secondary objective: To evaluate the safety of oral administration of the test preparation candesartan cilexetil hydrochlorothiazide tablets (Ⅱ) and the reference preparation candesartan cilexetil hydrochlorothiazide tablets (Ⅱ) in healthy subjects under fasting and high-fat meal administration conditions.