2023-503945-78-00已完成1 期
Randomized, double-blind, placebo-controlled study assessing the safety, tolerability, pharmacokinetics and pharmacodynamics of pitolisant after repeated oral ascending doses for 14 days, including the pitolisant effect on cardiac repolarization in healthy volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
研究概览
简要总结
暂无简介。
入排标准
- 年龄范围
- 18 years 至 64 years(18-64 Years)
- 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
研究者
Clinical Development Director
Scientific
Bioprojet Pharma
研究点 (1)
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