NCT03316820已完成1 期
A Randomized, Open Label, Four Period, Four Sequence, Single Dose, Crossover Study to Evaluate Relative Bioavailability of K0706 24 mg Tablet Formulation Relative to 24 mg Capsule Formulation Under Fasted Conditions and to Evaluate the Food Effect for Tablet Formulation 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
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Observed peak plasma concentration
研究概览
简要总结
This is single-center, single-dose, randomized, open-label, four-period, four sequence crossover study to evaluate the relative bioavailability of K0706 24 mg tablet formulation relative to 24 mg capsule formulation under fasted conditions and to evaluate the food-effect for tablet formulation 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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willingness to provide written, informed consent for participation in the study in the compliance with the protocol requirements
- •Adult males or females aged between 18 and 55 years
- •Medically healthy on the basis of medical history and physical examination
- •Woman of childbearing potential must practice an acceptable method of birth control
排除标准
- •History of any major surgical or medical conditions within 4 weeks prior to dosing
- •History of blood transfusion and / or plasmapheresis within 4 weeks prior to dosing
- •Inability to swallow oral medication and / or difficulty to find peripheral access to veins or inability to undergo venipuncture
- •Any malignancy within the past 3 years (except for non-melanoma skin cancer or cervical cancer in situ)
研究组 & 干预措施
Treatment A
Experimental
K0706 tablet
干预措施: K0706 (Drug)
Treatment B
Experimental
K0706 tablet
干预措施: K0706 (Drug)
Treatment C
Experimental
K0706 tablet
干预措施: K0706 (Drug)
Treatment D
Experimental
K0706 capsule
干预措施: K0706 (Drug)
结局指标
主要结局
Observed peak plasma concentration
时间窗: 72 hours
次要结局
- Adverse event(26 days)
研究者
研究点 (1)
Loading locations...
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