NCT03473626已完成1 期
A Two-Period, Randomised, Crossover Study Designed to Evaluate the In Vivo Performance of a Modified Release Formulation of Alicaforsen in Healthy Male Subjects in the Fed and Fasted State
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
- 15
- 试验地点
- 1
- 主要终点
- Pharmacokinetics
研究概览
简要总结
Phase 1 study to compare the effect of food on alicaforsen tablet.
详细描述
A study on healthy male vounteers in a phase 1 unit. Alicaforsen tablets are gievn in a fed and fasted state
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteer
排除标准
- •Drugs of abuse
- •Alcohol abuse
研究组 & 干预措施
Alicaforsen tablets
Experimental
Regimen A - Alicaforsen tablets with food
干预措施: Alicaforsen (Drug)
alicaforsen tablets
Experimental
Regimen B - Alicaforsen tablets without food
干预措施: Alicaforsen (Drug)
结局指标
主要结局
Pharmacokinetics
时间窗: 24 hours
Area under the curve recovery of alicaforsen in plasma
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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