NCT01716897已完成1 期
A Randomized, Open-label, 3-treatment Crossover Study to Determine the Bioavailability of E2609 Tablets Compared to Capsules and the Effect of Food on Absorption in Healthy Caucasian Male Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- AUC(0-inf) ratio, new tablet vs. capsule
研究概览
简要总结
This study will be a single-center, open-label, randomized, 3-treatment crossover study of single oral doses of an API-capsule formulation of E2609 under fasted conditions and a tablet formulation administered under fed and fasted conditions in healthy subjects.
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
- None
入排标准
- 年龄范围
- 30 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
50 mg E2609 tablet formulation in fasted state
Other
50 mg E2609 tablet formulation in fasted state
干预措施: E2609 (Drug)
50 mg tablet formulation in fed state
Other
50 mg E2609 tablet formulation in fed state
干预措施: E2609 (Drug)
50 mg E2609 capsule formulation in fasted state
Other
50 mg E2609 capsule formulation
干预措施: E2609 (Drug)
结局指标
主要结局
AUC(0-inf) ratio, new tablet vs. capsule
时间窗: 0 -144 hours
AUC(0-inf) ratio, fed state vs. fasted state, both after administration of new tablet
时间窗: 0 - 144 hours
Cmax ratio, new tablet vs. capsule
时间窗: 0 - 144 hours
Cmax ratio, fed state vs. fasted state, both after administration of new tablet
时间窗: 0 - 144 hours
次要结局
- incidence of Adverse events(5.5 weeks)
研究者
研究点 (1)
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