Clinical Pharmacology Study of Final Formulation of FYU-981 Administered to Healthy Male Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (CLtot/F: Total clearance/Fraction of dose absorbed)
研究概览
简要总结
This is a randomized, open-label, 2-period crossover study. The purpose of this study is to assess the pharmacokinetics and safety after single oral administration of final formulation of FYU-981 to healthy male adults in fasted and fed conditions. Participants are randomized to fasted (n=6) or fed conditions (n=6) in each step. The effect of food to pharmacokinetics of FYU-981 is also investigated.
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
- 20 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Japanese healthy adult subjects
- •Body mass index: >=18.5 and <25.0
排除标准
- •Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study
研究组 & 干预措施
Fasted dosing followed by fed dosing
Dosing of FYU-981 in the fasted state followed by fed dosing
干预措施: FYU-981 (Drug)
Fed dosing followed by fasted dosing
Dosing of FYU-981 in the fed state followed by fasted dosing
干预措施: FYU-981 (Drug)
结局指标
主要结局
Pharmacokinetics (CLtot/F: Total clearance/Fraction of dose absorbed)
时间窗: 48 hours
Pharmacokinetics (MRT: Mean residence time)
时间窗: 48 hours
Safety (Incidence of treatment-emergent adverse events)
时间窗: 13 days
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
时间窗: 48 hours
Pharmacokinetics (Vd/F: Distribution volume/Fraction of dose absorbed)
时间窗: 48 hours
Pharmacokinetics (kel: Elimination rate constant)
时间窗: 48 hours
Pharmacokinetics (Cmax: Maximum plasma concentration)
时间窗: 48 hours
Pharmacokinetics
时间窗: 48 hours
T1/2: Elimination half-life of plasma concentration
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
时间窗: 48 hours
次要结局
未报告次要终点