NCT01673880已完成1 期
A Single-center, Open-label, Randomized, Multi-cohort, Crossover Study of Relative Bioavailability of Tablet Versus Capsule Formulation of E2006 in Healthy Adult Subjects
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
- 40
- 试验地点
- 1
- 主要终点
- Plasma concentrations of E2006 of tablet vs. capsule formulations
研究概览
简要总结
This is a single-center, open-label, randomized crossover study being conducted in three cohorts of healthy adult subjects. Approximately 36 subjects will be randomized to one of three cohorts (approximately 12 subjects per cohort) and they will receive both a single dose of E2006 in capsule formulation and a single dose of E2006 in tablet formulation, in random sequence, at a 1:1 ratio. The doses to be tested will be 2.5 mg, 10 mg, and 25 mg.
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
- 18 Years 至 55 Years(Adult)
- 性别
- All
- 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
E2006 10mg
Other
干预措施: E2006 (Drug)
E2006 2.5 mg
Other
干预措施: E2006 (Drug)
E2006 25 mg
Other
干预措施: E2006 (Drug)
结局指标
主要结局
Plasma concentrations of E2006 of tablet vs. capsule formulations
时间窗: up to 336 hours post-dose
次要结局
- Incidence of adverse events (AEs)(36 days)
研究者
研究点 (1)
Loading locations...
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