A Phase 1 Study to Evaluate the Safety and PK/PD Drug-drug Interaction Between Epaminurad and Naproxen or to Assess the Safety and Multiple-Dose PK/PD Characteristics of Epaminurad in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 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 Phase 1 Study to evaluate the safety, PK/PD, drug-drug interaction(DDI) of Epaminurad and Naproxen in Healthy Volunteers
详细描述
Part 1: to evaluate the safety, PK/PD, drug-drug interaction(DDI) of Epaminurad and Naproxen in Healthy Koreans/ Part 2: to evaluate the safety, PK/PD of Epaminurad in Healthy Caucasians
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
PART 1: None (Open Label)/ PART 2: Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 19~50
- •Weight: between 50.0 kg~90.0 kg, Body Mass Index(BMI): 18.0 kg/m^2 or heavier and below 30.0 kg/m^2
- •Part 1: Korean/ Part 2: Caucasian
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) < 90mL/min/1.73m^2, Serum uric acid < 3 mg/dL or > 7 mg/dL, AST (SGOT), ALT (SGPT) > upper limit of normal ranges X 1.5, Total bilirubin, γ-GTP > upper limit of normal ranges X 1.5, CK > upper limit of normal ranges X 2, Positive serologic results Cystatin C > 1.26mg/L (man), > 1.19 mg/L (woman)
研究组 & 干预措施
Part 2(Test group)
Epaminurad 6 mg, Epaminurad 9 mg
干预措施: Epaminurad (Drug)
Part 2(Control group)
Epaminurad 6 mg placebo, Epaminurad 9 mg placebo
干预措施: Epaminurad placebo (Drug)
Part 1
Epaminurad 6 mg, Epaminurad 9 mg, Naproxen 500 mg
干预措施: Epaminurad, Naproxen (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC)
时间窗: 5 days
To evaluate the AUC of Naproxen
Peak plasma concentrations (Cmax)
时间窗: 7 days
To evaluate the Cmax of Epaminurad
Area under the plasma concentration versus time curve (AUC)
时间窗: 7 days
To evaluate the AUC of Epaminurad
Peak plasma concentrations (Cmax)
时间窗: 5 days
To evaluate the Cmax of Naproxen
次要结局
未报告次要终点