[Translation] A multi-center, randomized, double-blind, parallel-controlled, phase II/III clinical trial to evaluate the efficacy and safety of AR882 capsules compared with 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) Main purpose: To explore the effectiveness of AR882 capsules in the treatment of patients with primary gout and hyperuricemia to determine the dosing regimen for the Phase III study.
(2) Secondary purpose: to explore the safety of AR882 capsules in patients with primary gout and hyperuricemia; based on the population pharmacokinetics (PopPK) analysis method, to explore the safety of AR882 capsules in patients with primary gout and hyperuricemia. Pharmacokinetic (PK) characteristics in patients with AR882 and AR896; explore the relationship between exposure and effects of AR882 and AR896.
Phase III:
(1) Main purpose: To evaluate the effectiveness of AR882 capsules in the treatment of patients with primary gout and hyperuricemia
(2) Secondary purpose: 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; Exploring the relationship between exposure and effects of AR882 and AR896