NCT01044524已完成1 期
An Open Label Study to Determine ADME of 14C Labeled SLV334 and Its Metabolites After Single Intravenous Dose Infusion
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Percentage excreted in urine and feces
研究概览
简要总结
This study will investigate the absorption, distribution, metabolism and excretion after giving 2000 mg 14C-SLV334 via a 1-hour infusion. The absolute bioavailability will also be determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Percentage excreted in urine and feces
时间窗: 16 days
AUC, CL, lambda z, Cmax, t1/2, tmax and Vss
时间窗: 16 Days
metabolic profile SLV334
时间窗: 16 days
次要结局
- vital signs(16 days)
- Laboratory safety variables(16 days)
- Physical examination(16 days)
- ECG(16 days)
- adverse events(16 days)
研究者
研究点 (1)
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