NCT01450839已完成1 期
E2022 Patch Formulation Multiple Dose Phase I Study
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
- 16
- 主要终点
- Composite (or Profile) of Pharmacokinetics
研究概览
简要总结
This study is to evaluate the safety and tolerability of a E2022 16 mg tape when applied repeatedly for 17 days to healthy elderly Japanese male subjects, using E2022 placebo tape as the control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
E2020 5 mg tablet and tape
Experimental
干预措施: E2022 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Composite (or Profile) of Pharmacokinetics
时间窗: predose, 0,1, 2, 3, 4, 6, 8,1 2, 24, 48, 72, 96 hours post-dose
Cmax, Area Under Curve, Tmax
次要结局
未报告次要终点
研究者
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