NL-OMON45578已完成不适用
An open-label study to assess the absorption, distribution, metabolism and excretion, including the mass balance of [14C] labeled BIA 5-1058 and metabolites following a single oral dose administration in healthy male subjects<br> - 14C-BIA 5-1058 human ADME and mass balance study
Bial Portela & Ca.0 个研究点目标入组 8 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Healthy male subjects
- •18-65 years old, inclusive (of which at least 2 subjects of *55 years of age)
- •Body mass index: 18.0-30.0 kg/m2, inclusive, at screening
排除标准
- •Suffering from hepatitis B, hepatitis C, HIV/AIDS. Donation or loss of more than 100 mL of blood within 90 days prior to drug administration. Donation or loss of more than 1.5 liters of blood in the 10 months prior to drug administration in the current study. Participation in another ADME study with a radiation burden >0.1 mSv in the period of 1 year prior to screening.
研究者
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