NCT01747564已完成1 期
A Study to Evaluate Pharmacokinetics of Mirabegron After Single and Multiple Oral Administration to Healthy Non-elderly Male and Female Chinese Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Pharmacokinetic (PK) profile for ASP015K (in plasma): Cmax, AUClast, AUCinf and AUC0-24h
研究概览
简要总结
The purpose of this study is to evaluate safety and absorption, distribution and elimination of mirabegron after oral administration to Chinese subjects.
详细描述
This study is an open-label study. The subjects will receive single administration of mirabegron in a fasted condition. After the non-dosing period, subjects will receive mirabegron for 8 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 44 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body weight: (male) over 50.0kg and less than 80.0kg (female) over 40.0kg and less than 70.0kg
- •Body Mass Index: over 17.6 and less than 26.4 kg/m
- •Chinese subjects
- •Healthy judged by investigator or sub-investigator
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
- •Received mirabegron beforehand
- •Glaucoma patient
研究组 & 干预措施
mirabegron group
Experimental
干预措施: YM178 (mirabegron) (Drug)
结局指标
主要结局
Pharmacokinetic (PK) profile for ASP015K (in plasma): Cmax, AUClast, AUCinf and AUC0-24h
时间窗: Day 1-5 and Day 10, 11, 14-21
Maximum concentration (Cmax), Area under the curve (AUC) from time 0 extrapolated to infinity (AUCinf), AUC from time of dosing to last quantifiable concentration (AUClast ), and AUC from time 0 to 24hr (AUC0-24h)
次要结局
- Safety assessed by the incidence of adverse events, vital signs, lab-test and 12-lead ECGs(Through day 25)
研究者
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