Pharmacokinetic Study of ASP1941 -A Pharmacokinetic Study to Assess Drug-Drug Interaction Between ASP1941 and Mitiglinide Calcium Hydrate
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Pharmacokinetics of ASP1941 and Mitiglinide calcium hydrate assessed by its plasma concentration change
研究概览
简要总结
This study is to assess the pharmacokinetic interaction between ASP1941 and Mitiglinide calcium hydrate in healthy volunteers.
详细描述
This will be a randomized, open label, four group, two-way crossover design study to assess the effect of drug interaction between ASP1941 and Mitiglinide calcium hydrate on the pharmacokinetics of them after separate and concomitant administration to healthy non-elderly adult male subjects.
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
- 20 Years 至 44 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and laboratory tests
- •Body weight ; ≥50.0 kg, <80.0 kg
- •Body Mass Index ; ≥17.6, <26.4 kg/m2
- •Written informed consent has been obtained
排除标准
- •Received any investigational drugs within 120 days before the screening assessment
- •Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or d components within 14 days before the screening assessment
- •Received medication within 7 days before hospital admission
- •A deviation from the assessment criteria of physical examinations or laboratory tests at screening or upon admission
- •History of drug allergies
- •With renal, hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases
- •Previous treatment with ASP1941
研究组 & 干预措施
Part 1
Subjects will receive "ASP1941 alone" and "ASP1941 + Mitiglinide calcium hydrate" in different orders.
干预措施: ASP1941 (Drug)
Part 1
Subjects will receive "ASP1941 alone" and "ASP1941 + Mitiglinide calcium hydrate" in different orders.
干预措施: Mitiglinide calcium hydrate (Drug)
Part 2
Subjects will receive "Mitiglinide calcium hydrate alone" and "ASP1941 + Mitiglinide calcium hydrate" in different orders.
干预措施: ASP1941 (Drug)
Part 2
Subjects will receive "Mitiglinide calcium hydrate alone" and "ASP1941 + Mitiglinide calcium hydrate" in different orders.
干预措施: Mitiglinide calcium hydrate (Drug)
结局指标
主要结局
Pharmacokinetics of ASP1941 and Mitiglinide calcium hydrate assessed by its plasma concentration change
时间窗: For up to 72 hours after each administration
次要结局
- Safety assessed by incidence of adverse event, vital signs, 12-lead ECG and laboratory tests(For up to 10 days)
- Pharmacokinetics of the metabolites of ASP1941 assessed by its plasma concentration change(For 72 hours after ASP1941 administration)