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NOT YET RECRUITING
NCT07498647
PHASE2

Clinical Trial of BR2251 Tablets for Patients With Primary Gout and Hyperuricemia

Sponsor: BioRay Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is a randomized, double-blind, non-befloxacin-controlled, multicenter, phase II clinical trial, evaluating the efficacy, safety, and pharmacokinetic characteristics of BR2251 tablets when administered multiple times in subjects with primary gout and hyperuricemia. This study is a dose exploration study, including a screening period (up to 2 weeks), a double-blind treatment period (12 weeks), and a follow-up period (2 weeks). The screened subjects were stratified based on whether their serum uric acid (sUA) was less than 480 μmol/L or greater than or equal to 480 μmol/L. They were randomly assigned to 4 treatment groups in a 1:1:1:1 ratio: the test drug group 1 (low-dose group), the test drug group 2 (medium-dose group), the test drug group 3 (high-dose group), and the control group (non-befloxacin tablets 40 mg), with 40 subjects in each group. Each group will use titration dosing.

Official title: A Multicenter, Randomized, Double-blind, Non-benzylisoxazole Propionic Acid (BIPA) Controlled Phase II Clinical Study Evaluating the Efficacy and Safety of BR2251 Tablets in Patients With Primary Gout and Hyperuricemia

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2026-04-01

Completion Date

2026-11-30

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

DRUG

BR2251

BR2251 low dose, mid dose, high dose, Titration regimen and Take orally once a day

DRUG

Febuxostat

Febuxostat(40mg) Titration regimen and Take orally once a day