A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of ASP1941
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Pharmacokinetics (PK) profiles of ASP1941 (in plasma): AUCinf, AUClast and Cmax
研究概览
简要总结
This study is to investigate the effect of food on the pharmacokinetics, the pharmacodynamics and safety of ASP1941 after administration of ASP1941 in healthy non-elderly adult male subjects.
详细描述
This will be a randomized, open-label, 3-way crossover design study to investigate the effect of food on the pharmacokinetics, the pharmacodynamics and safety of ASP1941 after administration of ASP1941 in healthy non-elderly adult male subjects. Each subject will receive a single dose of ASP1941 "under fasting condition", "before meal" and "after meal".
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 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
研究组 & 干预措施
under fasting condition group
Subjects will receive a single dose of ASP1941 under fasting condition
干预措施: ASP1941 (Drug)
before meal group
Subjects will receive a single dose of ASP1941 before meal
干预措施: ASP1941 (Drug)
after meal condition
Subjects will receive a single dose of ASP1941 after meal
干预措施: ASP1941 (Drug)
结局指标
主要结局
Pharmacokinetics (PK) profiles of ASP1941 (in plasma): AUCinf, AUClast and Cmax
时间窗: For 72 hours after each administration
Area under the curve (AUC) from time 0 extrapolated to infinity (AUCinf), AUC from time of dosing to last quantifiable concentration (AUClast ), and maximum concentration (Cmax)
次要结局
- Pharmacokinetics (PK) profiles of ASP1941 (in plasma): tmax, t1/2, apparent distribution volume, apparent body clearance(For 72 hours after each administration)
- Safety assessed by incidence of adverse event, vital signs, 12-lead ECG and laboratory tests(For 72 hours after each administration)
- Changes in urinary glucose excretion(Before and for 72 hours after each administration)