E2022 Patch Formulation Single Dose Phase I Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- Comparison of pharmacokinetics of E2022 patch (type A, B, C, D, E) with single dose of E2020 5 mg tablets.
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics of a single dose of E2022 in healthy Japanese male volunteers.
详细描述
This study is an open-label single site, randomized single dose study in 80 healthy Japanese male volunteers. The study consists of Period I to Period III, a total of 3 periods. In Period I, E2022 patches will be secured with seal. In Period II, single dose of E2022 5 mg tablet will be administered. In Period III, E2022 patches will be applied without seal. The features of the 5 patches will be evaluated in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 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
4
干预措施: E2022 (Drug)
2
干预措施: E2022 (Drug)
1
干预措施: E2022 (Drug)
5
干预措施: E2022 (Drug)
3
干预措施: E2022 (Drug)
结局指标
主要结局
Comparison of pharmacokinetics of E2022 patch (type A, B, C, D, E) with single dose of E2020 5 mg tablets.
时间窗: 15 days
次要结局
未报告次要终点