NCT01118559已完成1 期
Pharmacokinetic Study of YM150 - A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of YM150
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
- Plasma concentration of YM150 and its metabolites
研究概览
简要总结
This study is to evaluate the effect of food on the pharmacokinetics of YM150 in healthy male adult subjects.
详细描述
To evaluate the effect of food on the pharmacokinetics of YM150 in healthy non-elderly adult male subjects using a 2×2 crossover design. Also, to evaluate the safety of YM150.
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
- •Body weight: ≥50.0 kg, <80.0 kg
- •BMI: ≥17.6, <26.4
- •Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations and lab tests
排除标准
- •Received any investigational drugs within 120 days before the study
- •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 study
- •Received medication within 7 days before the study
- •A deviation from the assessment criteria of physical examinations or laboratory tests
- •A deviation from the normal reference range of coagulation test [PT or aPTT]
- •History of drug allergies
- •Upper gastrointestinal disease within 7 days before the study
- •Concurrent or previous hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases
- •Concurrent or previous malignant tumor
- •Previous treatment with YM150
研究组 & 干预措施
fast-fed sequence group
Experimental
drug is administered in a fasted condition first, and fed-condition study follows
干预措施: YM150 (Drug)
fed-fast sequence group
Experimental
drug is administered in a fed condition first, and fasted-condition study follows
干预措施: YM150 (Drug)
结局指标
主要结局
Plasma concentration of YM150 and its metabolites
时间窗: for 3 days after drug administration
次要结局
- Safety assessed by AEs, vital signs, 12-lead ECG and lab tests(for 3 days after drug administration)
- PT (prothrombin time)(for 3 days after drug administration)
- aPTT (activated partial thromboplastin time)(for 2 days after drug administration)
- FXa (factor Xa) activity(for 1 days after drug administration)
研究者
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