[Translation] A multicenter, randomized, double-blind, double-dummy, febuxostat- and placebo-controlled Phase IIa clinical study to evaluate the safety, tolerability, preliminary clinical efficacy, and pharmacokinetic/pharmacodynamic characteristics of THDBH151 tablets in adult patients with gout
主要目的:
1、 评估成人痛风患者口服THDBH151片的安全性和耐受性;
2、 评估成人痛风患者口服THDBH151片的初步有效性。
次要目的:
1、 评估成人痛风患者口服THDBH151片降尿酸作用;
2、 评估成人痛风患者口服THDBH151片的药代/药效动力学特征;
3、 评估口服THDBH151片对成人痛风患者痛风发作的影响;
4、 初步对比THDBH151片与非布司他片对成人痛风患者的降尿酸作用;
[Translation] Main objectives:
1. To evaluate the safety and tolerability of oral THDBH151 tablets in adult patients with gout;
2. To evaluate the preliminary effectiveness of oral THDBH151 tablets in adult patients with gout.
Secondary objectives:
1. To evaluate the uric acid-lowering effect of oral THDBH151 tablets in adult patients with gout;
2. To evaluate the pharmacokinetic/pharmacodynamic characteristics of oral THDBH151 tablets in adult patients with gout;
3. To evaluate the effect of oral THDBH151 tablets on gout attacks in adult patients with gout;
4. To preliminarily compare the uric acid-lowering effects of THDBH151 tablets and Febuxostat tablets in adult patients with gout;