[Translation] A single-center, randomized, open-label, single-dose, two-period, double-crossover relative bioavailability study of AR882 capsules in healthy subjects under fasting conditions
(1)主要目的:在空腹给药条件下,比较广州瑞安博医药科技有限公司研制的AR882胶囊(规格:25 mg)与BioDuro LLC生产的AR882胶囊(规格:25 mg)在中国健康成年人群中吸收程度和速度的差异,评价其相对生物利用度。(2)次要目的:评价广州瑞安博医药科技有限公司研制的AR882胶囊(规格:25 mg)在中国健康受试者中的安全性和耐受性。(3)探索性目的:研究中国健康受试者口服AR882胶囊(规格:25 mg)后的药效动力学(PD)特征。
[Translation] (1) Primary objective: To compare the differences in the extent and rate of absorption of AR882 capsules (specification: 25 mg) developed by Guangzhou Ruianbo Pharmaceutical Technology Co., Ltd. and AR882 capsules (specification: 25 mg) produced by BioDuro LLC in healthy Chinese adults under fasting conditions, and to evaluate their relative bioavailability. (2) Secondary objective: To evaluate the safety and tolerability of AR882 capsules (specification: 25 mg) developed by Guangzhou Ruianbo Pharmaceutical Technology Co., Ltd. in healthy Chinese subjects. (3) Exploratory objective: To study the pharmacodynamic (PD) characteristics of AR882 capsules (specification: 25 mg) after oral administration in healthy Chinese subjects.