CTRI/2009/091/000628未知1/2 期
An open-label, randomized, 2-period, cross-over study to determine the relative bioavailability of AEB071 from a coated tablet versus a capsule in healthy subjects
试验速览
- 阶段
- 1/2 期
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- To determine the relative bioavailability of AEB071 from a coated tablet versus an immediate-release capsule
研究概览
简要总结
An open-label, randomized, 2-period, cross-over study to determine the relative bioavailability of AEB071 from a tablet formulation versus a capsule formulation in healthy subjects. Results will be used to guide formulation development decisions.
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
入选标准
- •Health volunteers of either gender between 18 to 45 years.Women should be postmenopausal or surgically sterializedMales should be using contraception.
排除标准
- •SmokersHistory of any major illness, and abnormal lab assessmentThose who have intension to vaccine for 2 weeks or have had vaccine in the last 2 weeks.
结局指标
主要结局
To determine the relative bioavailability of AEB071 from a coated tablet versus an immediate-release capsule
时间窗: NIL
次要结局
- To assess the safety and tolerability of AEB071 after single-dose administrations(NIL)
研究者
研究点 (1)
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