NCT01125657已完成1 期
Pharmacokinetic Study of YM150 - The Verification ot the Bioequivalence Between YM150 Formulation-A and YM150 Formulation-B -
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
- 44
- 主要终点
- Plasma concentration of YM150 and its metabolites measured by blood sample
研究概览
简要总结
This study is to compare its pharmacokinetics profile of two YM150 formulations by 2x2 crossover method.
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 (INR) 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
formualation-A to -B sequence group
Experimental
干预措施: YM150 (Drug)
formulation-B to -A sequence group
Experimental
干预措施: YM150 (Drug)
结局指标
主要结局
Plasma concentration of YM150 and its metabolites measured by blood sample
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(or 3 days after drug administration)
研究者
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