/ Not yet recruitingPhase 1 F-02-2-Na片在成年受试者中的I期临床试验研究
[Translation] Phase I clinical trial of F-02-2-Na tablets in adult subjects
主要目的: 1.评估成年受试者单次口服 F-02-2-Na 片后的药动学特征; 2.评估成年受试者单次口服 F-02-2-Na 片后的安全性。
次要目的:
1.评估食物对F-02-2-Na片药代动力学特征的影响;
2.评估成年受试者单次口服 F-02-2-Na 片后的效应:sUA变化的绝对值、百分比值、达标率(≤360 μmol/L);
3.探索尿酸排泄相关指标(AeUR、CLUR、FEUA)、sUA动态变化曲线(AUC)、24小时尿酸排泄总量。
[Translation] Primary Objectives:
1. To evaluate the pharmacokinetic characteristics of a single oral dose of F-02-2-Na tablets in adult subjects;
2. To evaluate the safety of a single oral dose of F-02-2-Na tablets in adult subjects.
Secondary Objectives:
1. To evaluate the effect of food on the pharmacokinetic characteristics of F-02-2-Na tablets;
2. To evaluate the effects of a single oral dose of F-02-2-Na tablets in adult subjects: absolute value, percentage value, and target achievement rate (≤360 μmol/L);
3. To explore uric acid excretion-related indicators (AeUR, CLUR, FEUA), the dynamic change curve of sUA (AUC), and the total 24-hour uric acid excretion.
100 Clinical Results associated with Guangdong Hengqin Xinchuangyi Biopharmaceutical Co., Ltd.
0 Patents (Medical) associated with Guangdong Hengqin Xinchuangyi Biopharmaceutical Co., Ltd.
100 Deals associated with Guangdong Hengqin Xinchuangyi Biopharmaceutical Co., Ltd.
100 Translational Medicine associated with Guangdong Hengqin Xinchuangyi Biopharmaceutical Co., Ltd.