[Translation] A multicenter, randomized, double-blind, parallel-controlled, phase II/III clinical trial to evaluate the efficacy and safety of AR882 capsules versus febuxostat tablets in the treatment of patients with primary gout and hyperuricemia
II期:
(1)主要目的:探索AR882胶囊治疗原发性痛风伴高尿酸血症患者的有效性,以确定III期研究的给药方案。
(2)次要目的:探索AR882胶囊在原发性痛风伴高尿酸血症患者中的安全性;基于群体药代动力学(PopPK)分析方法,探索AR882胶囊在原发性痛风伴高尿酸血症患者中的药代动力学(PK)特征;探索AR882和AR896的暴露与效应之间的关系。
III期:
(1)主要目的:评价AR882胶囊治疗原发性痛风伴高尿酸血症患者的有效性
(2)次要目的:评价AR882胶囊在原发性痛风伴高尿酸血症患者中的安全性;基于PopPK分析方法,探索AR882胶囊在原发性痛风伴高尿酸血症患者中的PK特征;探索AR882和AR896的暴露与效应之间的关系
[Translation] Phase II:
(1) Primary objective: To explore the efficacy of AR882 capsules in the treatment of patients with primary gout and hyperuricemia, so as to determine the dosing regimen for Phase III studies.
(2) Secondary objectives: To explore the safety of AR882 capsules in patients with primary gout and hyperuricemia; to explore the pharmacokinetic (PK) characteristics of AR882 capsules in patients with primary gout and hyperuricemia based on the population pharmacokinetic (PopPK) analysis method; to explore the relationship between exposure and effect of AR882 and AR896.
Phase III:
(1) Primary objective: To evaluate the efficacy of AR882 capsules in the treatment of patients with primary gout and hyperuricemia
(2) Secondary objectives: To evaluate the safety of AR882 capsules in patients with primary gout and hyperuricemia; to explore the PK characteristics of AR882 capsules in patients with primary gout and hyperuricemia based on the PopPK analysis method; to explore the relationship between exposure and effect of AR882 and AR896