[Translation] A single-center, randomized, open-label, single-dose, two-period, two-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,不同场地原料药制备的AR882胶囊(受试制剂T vs 原制剂R)在健康受试者中的相对生物利用度研究。
(2)次要目的:评价广州瑞安博医药科技有限公司研制的AR882胶囊在健康受试者中的安全性和耐受性;
(3)探索性目的:研究健康受试者口服AR882胶囊的药效动力学(PD)特征。
[Translation] (1) Primary objective: To study the relative bioavailability of AR882 capsules prepared from raw materials at different sites (test formulation T vs. original formulation R) in healthy subjects under fasting administration conditions.
(2) Secondary objective: To evaluate the safety and tolerability of AR882 capsules developed by Guangzhou Ruianbo Pharmaceutical Technology Co., Ltd. in healthy subjects.
(3) Exploratory objective: To study the pharmacodynamic (PD) characteristics of oral administration of AR882 capsules in healthy subjects.