[Translation] A single-center, randomized, open-label, two-dose, two-period, two-sequence, single-dose, double-crossover bioequivalence study of tamsulosin hydrochloride extended-release capsules in Chinese healthy adult male subjects under fasting and fed conditions
主要目的:以药代动力学参数作为主要终点评价指标,分别比较在空腹
/餐后状态下口服受试制剂盐酸坦索罗辛缓释胶囊(规格:0.2mg,生产
厂家:上海惠永制药有限公司)与参比制剂盐酸坦索罗辛缓释胶囊(规
格:0.2mg,持证商:安斯泰来制药(中国)有限公司,商品名:哈乐®)
后在健康研究参与者体内的药代动力学行为,评价两种制剂的生物等效
性。
次要目的:观察受试制剂盐酸坦索罗辛缓释胶囊和参比制剂盐酸坦索罗
辛缓释胶囊在健康研究参与者中的安全性。
[Translation] Primary Objective: To compare the pharmacokinetic behavior of the test formulation, tamsulosin hydrochloride extended-release capsules (0.2 mg, manufacturer: Shanghai Huiyong Pharmaceutical Co., Ltd.), and the reference formulation, tamsulosin hydrochloride extended-release capsules (0.2 mg, licensee: Astellas Pharma (China) Co., Ltd., trade name: Harle®), in healthy study participants after oral administration in the fasting and fed states, using pharmacokinetic parameters as primary endpoints, and to evaluate the bioequivalence of the two formulations.
Secondary Objective: To observe the safety of the test formulation, tamsulosin hydrochloride extended-release capsules, and the reference formulation, tamsulosin hydrochloride extended-release capsules, in healthy study participants.