NCT07036458进行中（未招募）1 期
An Open-label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C Epaminurad in Healthy Male Subjects
JW Pharmaceutical1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2025年8月22日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Mass balance recovery of total radioactivity in all excreta (urine and faeces)
研究概览
简要总结
To Evaluate the Mass Balance Recovery, Metabolite Profile and Metabolite Identification in Healthy Male Subjects
详细描述
The following blood, urine and faecal samples will be collected, and assessments performed, at specified time points
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •1. Healthy volunteers
排除标准
- •1. Subjects does not meet the Inclusion Criteria
研究组 & 干预措施
Subjects will receive a single administration of 14C Epaminurad Oral Solution
Other
干预措施: 14C Epaminurad Oral Solution (Drug)
结局指标
主要结局
Mass balance recovery of total radioactivity in all excreta (urine and faeces)
时间窗: Baseline to Day 8
Collection of plasma, urine and faeces samples during time frame point
Metabolite profling and structural identification
时间窗: Baseline to Day 8
Collection of plasma, urine and faeces samples during time frame point
次要结局
未报告次要终点
研究者
研究点 (1)
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