NCT01765855已完成1 期
AN OPEN-LABEL, SINGLE-DOSE, MASS-BALANCE STUDY TO ASSESS THE DISPOSITION OF 14C-LABELED PRT054021 IN HEALTHY MALE SUBJECTS
Portola Pharmaceuticals0 个研究点目标入组 5 人开始时间: 2007年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 主要终点
- mean (max, tmax, AUC)
研究概览
简要总结
This is a open label, single center, single oral dose, study of PRT054021, in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adult men ages of 19 and 55 years old, inclusive
- •weighs at least 132 lbs
排除标准
- •Clinically significant comorbid disease
- •History of substance abuse
- •Hemoglobin less than 12.0 g/dl
研究组 & 干预措施
Single Arm Oral Betrixaban
Experimental
干预措施: Betrixaban single oral dose (Drug)
结局指标
主要结局
mean (max, tmax, AUC)
时间窗: Over 336 hours
次要结局
- Percent dose recovered in urine and feces(Over 336 hours)
研究者
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