NCT00965926已完成1 期
A Pharmacokinetic Study in Healthy Non-elderly Male and Female Volunteers to Investigate the Effect of Food on the Pharmacokinetics of YM178
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
- 72
- 主要终点
- Plasma concentration of unchanged YM178
研究概览
简要总结
The purpose of the study is to evaluate the effect of food intake on the pharmacokinetics of YM178 in healthy, non-elderly adult 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 54 Years（Adult）
- 性别
- All
- 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 all lab tests
- •Body weight (at screening); female ≥40.0 kg, <70.0 kg, male ≥50.0 kg, <80.0 kg
- •BMI (at screening): ≥17.6, <26.4
- •Written informed consent has been obtained
排除标准
- •Received any investigational drugs within 120 days before the screening test
- •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 test
- •Received medication within 7 days before hospital admission or is scheduled to receive medication
- •Females who are lactating, pregnant, potentially child-bearing, or willing to get pregnant during the study period
- •History of drug allergies
- •Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before hospital admission
研究组 & 干预措施
Low dose group
Experimental
3 way cross-over. Fasting, normal diet and high-fat diet
干预措施: YM178 (Drug)
High dose group
Experimental
3 way cross-over. Fasting, normal diet and high-fat diet
干预措施: YM178 (Drug)
结局指标
主要结局
Plasma concentration of unchanged YM178
时间窗: Up to 96 hours post dose
次要结局
- Urinary concentration of unchanged YM178(Up to 96 hours post dose)
研究者
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