[Translation] A randomized, open-label, two-period, double-crossover bioequivalence study of irbesartan and hydrochlorothiazide tablets in healthy volunteers under fasting and fed conditions
主要目的:本研究以天津华津制药有限公司生产的厄贝沙坦氢氯噻嗪片(规格:每片含厄贝沙坦 150mg 和氢氯噻嗪 12.5mg)为
受试制剂,按生物等效性试验的有关规定,以 Sanofi Winthrop Industrie 生产的厄贝沙坦氢氯噻嗪片(商品名:安博诺®,规格:
150mg/12.5mg:每片含厄贝沙坦 150mg,氢氯噻嗪 12.5mg)为参比制剂,进行空腹/餐后状态下人体生物等效性试验,评价受试制
剂和参比制剂在健康受试者体内的生物等效性。
次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main purpose: This study used irbesartan hydrochlorothiazide tablets (specification: each tablet contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide) produced by Tianjin Huajin Pharmaceutical Co., Ltd. as the test preparation. According to the relevant provisions of the bioequivalence test, irbesartan hydrochlorothiazide tablets (trade name: Ambeno®, specification: 150 mg/12.5 mg: each tablet contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide) produced by Sanofi Winthrop Industrie were used as the reference preparation. Human bioequivalence tests were conducted under fasting/fed conditions to evaluate the bioequivalence of the test preparation and the reference preparation in healthy subjects. Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.