[Translation] A single-center, randomized, open-label, fasting and postprandial single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of irbesartan/hydrochlorothiazide tablets in healthy adult subjects in China.
主要研究目的:
考察空腹和餐后单次口服受试制剂厄贝沙坦氢氯噻嗪片(规格:150 mg/12.5 mg:每片含厄贝沙坦150 mg,氢氯噻嗪12.5 mg,元和药业股份有限公司生产)与参比制剂厄贝沙坦氢氯噻嗪片(商品名:安博诺®;COAPROVEL®,规格:150 mg/12.5 mg:每片含厄贝沙坦150 mg,氢氯噻嗪12.5 mg,Sanofi Winthrop Industrie生产),在中国健康人体的相对生物利用度,分析两种制剂的药代动力学参数,评价两制剂的生物等效性。
次要研究目的:
评价空腹和餐后单次口服厄贝沙坦氢氯噻嗪片在中国成年健康受试者中的安全性。
[Translation] Primary Objective: To investigate the relative bioavailability of the test formulation, irbesartan/hydrochlorothiazide tablets (150 mg/12.5 mg: each tablet contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide, manufactured by Yuanhe Pharmaceutical Co., Ltd.), and the reference formulation, irbesartan/hydrochlorothiazide tablets (trade name: Ambono®; COAPROVEL®, 150 mg/12.5 mg: each tablet contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide, manufactured by Sanofi Winthrop Industrie), in healthy Chinese subjects after a single oral administration on both fasting and after a meal. Pharmacokinetic parameters of the two formulations were analyzed, and their bioequivalence was evaluated.
Secondary Objective: To evaluate the safety of irbesartan/hydrochlorothiazide tablets after a single oral administration on both fasting and after a meal in healthy adult Chinese subjects.