NCT01322451已完成1 期
A Randomized, Open Label, 2-way Crossover Study to Compare the Oral Bioavailability of 2 Solid Dose Formulations of GLPG0259 After Single-dose Intake in Healthy 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
- Galapagos NV
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Bioavailability of two solid dosage formulations of GLPG0259
研究概览
简要总结
The purpose of the study is to evaluate the relative bioavailability of two solid oral formulations of GLPG0259 administered after a meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy male, age 18-50 years
- •BMI between 18-30 kg/m², inclusive.
排除标准
- •significantly abnormal platelet function or coagulopathy
- •drug or alcohol abuse
研究组 & 干预措施
Single oral dose, single capsule
Experimental
干预措施: GLPG0259 free base (Drug)
Single oral dose, two capsules
Experimental
干预措施: GLPG0259 fumarate (Drug)
结局指标
主要结局
Bioavailability of two solid dosage formulations of GLPG0259
时间窗: up to 96 hours postdose
次要结局
- Safety and tolerability of GLPG0259(up to 96 hours postdose)
研究者
研究点 (1)
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