NCT01232023Unknown1 期
Evaluation of Pharmacokinetic and Pharmacodynamic Characteristics of Indobufen, an Anticoagulant Agent
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Pharmacokinetics
研究概览
简要总结
This study is designed to evaluate the pharmacokinetic and pharmacodynamic characteristics of indobufen in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adult males aged 19 to 50 years at screening.
- •Subjects with body weight ≥ 45 kg and within ±20% of the ideal body weight : Ideal body weight = (height [cm] - 100)x0.
- •Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.
排除标准
- •Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study.
- •Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.
研究组 & 干预措施
800mg
Experimental
Wild type UGT1A : 3 / Variant type UGT1A : 3
干预措施: Indobufen (Drug)
100mg
Experimental
Wild type UGT1A : 3 / Variant type UGT1A : 3
干预措施: Indobufen (Drug)
200mg
Experimental
Wild type UGT1A : 3 / Variant type UGT1A : 3
干预措施: Indobufen (Drug)
400mg
Experimental
Wild type UGT1A : 3 / Variant type UGT1A : 3
干预措施: Indobufen (Drug)
结局指标
主要结局
Pharmacokinetics
时间窗: 24 Hours
AUC, Cmax
次要结局
- Pharmacodynamics(24 Hours)
研究者
研究点 (2)
Loading locations...
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