A Phase I Study to Assess Drug-Drug Interaction Between ASP1941 and Miglitol.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Pharmacokinetics of ASP1941 and Miglitol through analysis of blood samples
研究概览
简要总结
This study is to assess the pharmacokinetic interaction between ASP1941 and Miglitol in healthy volunteers.
详细描述
This will be a randomized, open-label, 3-way crossover design study to assess the drug-drug interaction between a single oral dose of ASP1941 and a single oral dose of Miglitol in healthy adult male volunteers. Each subject will receive "ASP1941 alone", "Miglitol alone" and "ASP1941 + Miglitol".
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
- •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 blood 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
one group
Subjects will receive "ASP1941 alone", "Miglitol alone" and "ASP1941 + Miglitol" in different order.
干预措施: ASP1941 (Drug)
one group
Subjects will receive "ASP1941 alone", "Miglitol alone" and "ASP1941 + Miglitol" in different order.
干预措施: Miglitol (Drug)
结局指标
主要结局
Pharmacokinetics of ASP1941 and Miglitol through analysis of blood samples
时间窗: For 72 hours after each administration
次要结局
未报告次要终点