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MechanismURAT1 inhibitors |
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Inactive Indication- |
Drug Highest PhasePhase 3 |
First Approval Ctry. / Loc.- |
First Approval Date- |
AR882胶囊在健康受试者中单中心、随机、开放、单剂量、双周期、双交叉空腹状态下的相对生物利用度试验
[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.
AR882胶囊在健康受试者中的单中心、随机、开放、单剂量、双周期、双交叉食物影响研究
[Translation] A single-center, randomized, open-label, single-dose, two-period, double-crossover food effect study of AR882 capsules in healthy subjects
(1)主要目的:评价食物(高脂高热量餐)对AR882胶囊(规格:25 mg)药代动力学的影响;
(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(规格:25 mg)在中国健康受试者中的安全性和耐受性;
(3)探索性目的:评价食物(高脂高热量餐)对AR882胶囊(规格:25 mg)的药效动力学的影响。
[Translation] (1) Primary objective: To evaluate the effect of food (high-fat, high-calorie meal) on the pharmacokinetics of AR882 capsules (specification: 25 mg);
(2) Secondary objective: To evaluate the safety and tolerability of AR882 capsules (specification: 25 mg) developed by Guangzhou Ruianbo Pharmaceutical Technology Co., Ltd. in healthy Chinese subjects;
(3) Exploratory objective: To evaluate the effect of food (high-fat, high-calorie meal) on the pharmacodynamics of AR882 capsules (specification: 25 mg).
/ Active, not recruitingPhase 2/3 A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase II/III Study to Evaluate the Efficacy and Safety of AR882 Capsules Compared to Febuxostat Tablets in Patients with Primary Gout and Hyperuricemia
The goal of this clinical trial is to evaluate the efficacy and safety of AR882 Capsules in patients with primary gout and hyperuricemia. The main questions it aims to answer are:
What is the efficacy of AR882 Capsules in reducing serum uric acid levels in patients with primary gout and hyperuricemia?
Researchers will compare AR882 Capsules with Febuxostat Tablets to see :
Phase II: To explore the efficacy of AR882 Capsules in patients with primary gout and hyperuricemia, aiming to determine the dosing regimen for the Phase III study Phase III: To evaluate the efficacy of AR882 Capsules in patients with primary gout and hyperuricemia.
Participants will:
Be randomly assigned to receive either AR882 Capsules or Febuxostat Tablets. Undergo regular assessments of serum uric acid levels. Report any adverse events or side effects experienced during the study.
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