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临床试验/NCT06435442
NCT06435442已完成1 期

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

JW Pharmaceutical1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2024年6月3日最近更新:
适应症
干预措施
相关药物

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

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)

Experimental

Epaminurad 6 mg, Epaminurad 9 mg

干预措施: Epaminurad (Drug)

Part 2(Control group)

Placebo Comparator

Epaminurad 6 mg placebo, Epaminurad 9 mg placebo

干预措施: Epaminurad placebo (Drug)

Part 1

Experimental

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

研究者

发起方
JW Pharmaceutical
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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