NCT02042729已完成1 期
A Phase 1 Comparative Study of E2022 Current and New Patch Formulations
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
- 34
- 主要终点
- Number of Adverse Events
研究概览
简要总结
The purpose of this study is to investigate the safety and pharmacokinetics of new patch formulation (tape) of E2022 by conducting patch test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 39 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
研究组 & 干预措施
E2022- Tape Formulation
Experimental
干预措施: E2022- Current Formula Tape (Drug)
Matching Placebo E2022
Placebo Comparator
Matching Placebo
干预措施: E2022 Matching Placebo- Current Formula Tape (Drug)
E2022- New Formulation
Active Comparator
干预措施: E2022- New Formula Tape (Drug)
Placebo E2022- New Formulation
Placebo Comparator
Matching Placebo
干预措施: E2022 Matching Placebo- New Formula Tape (Drug)
结局指标
主要结局
Number of Adverse Events
时间窗: 10 days (Cohort I) and 40 days (Cohort II)
Frequency of Adverse Events
时间窗: 10 days (Cohort I) and 40 days (Cohort II)
次要结局
- Pharmacokinetic Parameter: Tmax(40 days (Cohort II))
- Pharmacokinetic Parameter: AUC(40 days (Cohort II))
- Pharmacokinetic Parameter: Cmax(40 days (Cohort II))
研究者
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