NCT01843556已完成1 期
A Phase 1 Study of E2022 Tape Formulation for Different Application Sites and Intervals
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Number and frequency of adverse events
研究概览
简要总结
A phase 1 study of E2022 tape formulation in healthy elderly males to evaluate the safety and pharmacokinetics.
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
- 65 Years 至 —（Older 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
研究组 & 干预措施
E2022 Tape Formulation
Experimental
干预措施: E2022 Tape Formulation (Drug)
结局指标
主要结局
Number and frequency of adverse events
时间窗: 168 hours after the end of application
次要结局
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(216 hours after the end of application)
- Maximal Drug Concentration (CMax)(216 hours after the end of application)
- Area Under the Plasma Concentration-Time Curve (AUC)(216 hours after the end of application)
- Plasma Decay Half-Life (t1/2)(216 hours after the end of application)
研究者
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