A Randomized, Open-label, Single Dose, 2x2 Crossover Study to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of Epaminurad in Healthy Adult Volunteers Under Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve (AUC)
研究概览
简要总结
A randomized, open-label, single dose, 2x2 crossover study to evaluate the safety and pharmacokinetic characteristics after administration of Epaminurad in healthy adult volunteers under fasting conditions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 19~55
- •Weight: at least 50 kg for males and 45 kg for females. Body Mass Index(BMI): 18.0 kg/m^2 or heavier and below 30.0 kg/m^2
排除标准
- •Medical history- chronic liver disease, acute gout attack, uric acid stone, diabetes, hypertension, hyperlipidemia or lipid abnormality
- •Clinical examination- eGFR (CKD-EPI) < 60mL/min/1.73m^2, AST (SGOT), ALT (SGPT) > upper limit of normal ranges X 2, CK > upper limit of normal ranges X 5, Positive serologic results Cystatin C > 1.26mg/L
研究组 & 干预措施
Group 1
Subjects receive a single dose of Treatment A (JW Pharmaceutical) in Period 1, followed by a washout period, and then a single dose of Treatment B (Shanghai STA Pharmaceutical) in Period 2.
干预措施: Epaminurad 9 mg (JW Pharmaceutical) (Drug)
Group 1
Subjects receive a single dose of Treatment A (JW Pharmaceutical) in Period 1, followed by a washout period, and then a single dose of Treatment B (Shanghai STA Pharmaceutical) in Period 2.
干预措施: Epaminurad 9 mg (Shanghai STA Pharmaceutical) (Drug)
Group 2
Subjects receive a single dose of Treatment B (Shanghai STA Pharmaceutical) in Period 1, followed by a washout period, and then a single dose of Treatment A (JW Pharmaceutical) in Period 2.
干预措施: Epaminurad 9 mg (JW Pharmaceutical) (Drug)
Group 2
Subjects receive a single dose of Treatment B (Shanghai STA Pharmaceutical) in Period 1, followed by a washout period, and then a single dose of Treatment A (JW Pharmaceutical) in Period 2.
干预措施: Epaminurad 9 mg (Shanghai STA Pharmaceutical) (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC)
时间窗: 3 days
To evaluate the AUC of Epaminurad
Peak plasma concentrations (Cmax)
时间窗: 3 days
To evaluate the Cmax of Epaminurad
次要结局
未报告次要终点