NCT01563471已完成1 期
Single-centre, Randomised, Placebo-controlled, Double-blind, Dose Escalation Trial Investigating Pharmacokinetics, Pharmacodynamics and Tolerability of Three Different Single Intravenous Doses of Activated Recombinant Factor VIIa (rFVIIa/NovoSeven®) in Healthy Caucasian and Japanese Subjects
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
- 39
- 试验地点
- 1
- 主要终点
- Area under the Curve (AUC) of FVII:C (Factor VII clotting activity) from 0-24 hours
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics of three different single doses activated recombinant human factor VII in Caucasian and Japanese healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caucasian or Japanese
- •Healthy as defined by medical history, physical and biological examinations
排除标准
- •History of allergy or hypersensitivity reaction to any medication
- •History or presence of any organic disorder likely to modify absorption, distribution or elimination of the medication
- •Alcohol or substance abuse disorder
- •Subject in his exclusion period in the Healthy Volunteers National Register of the French Ministry of Health
研究组 & 干预措施
Treatment sequence 1
Experimental
干预措施: activated recombinant human factor VII (Drug)
Treatment sequence 1
Experimental
干预措施: placebo (Drug)
Treatment sequence 2
Experimental
干预措施: activated recombinant human factor VII (Drug)
Treatment sequence 2
Experimental
干预措施: placebo (Drug)
Treatment sequence 3
Experimental
干预措施: activated recombinant human factor VII (Drug)
Treatment sequence 3
Experimental
干预措施: placebo (Drug)
Treatment sequence 4
Placebo Comparator
干预措施: activated recombinant human factor VII (Drug)
Treatment sequence 4
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Area under the Curve (AUC) of FVII:C (Factor VII clotting activity) from 0-24 hours
次要结局
- Time to reach maximum plasma concentration (tmax)
- Mean residence time (MRT)
- Maximum plasma concentration (Cmax)
- Area under the Curve (AUC) from 0-24 hours of the PT (Prothrombin Time)
- Adverse events
研究者
研究点 (1)
Loading locations...
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