NCT01561417已完成1 期
A Single-centre, Randomised, Double-blind, Two-way Cross-over Trial Investigating the Bio-equivalence in Healthy Male Subjects of NovoSeven (CP-rFVIIa) and a Formulation of NovoSeven Stable at 25°C (VII25)
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
- 28
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve for FVIIa clot activity
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to demonstrate bio-equivalence between the marketed activated recombinant human factor VII (NovoSeven®) (CP-rFVIIa) and a new formulation stable at 25°C (VII25).
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Caucasian
- •Body Mass Index (BMI) between 18 and 27 kg/m^2, both inclusive
- •Good health as indicated by medical history, physical examination including vital signs and ECG, and clinical laboratory test results
- •Smoke less than 10 cigarettes (or equivalent) per day
- •Capable of giving written Informed Consent (IC)
排除标准
- •Evidence of clinically relevant pathology or potential thromboembolic risk based on medical and/or family history as judged by the Investigator
- •Known history of atherosclerosis, arteriosclerosis, thromboembolic events or known high levels of Troponin I
- •Known or suspected allergy to activated recombinant human factor VII or related products or any of the components of the formulation
- •Overt bleeding, including from gastrointestinal tract
- •Hepatitis (B or C) infection
- •HIV (human immunodeficiency virus) infection
研究组 & 干预措施
CP-rFVIIa
Active Comparator
干预措施: activated recombinant human factor VII (Drug)
VII25
Experimental
干预措施: activated recombinant human factor VII (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve for FVIIa clot activity
次要结局
- The maximum plasma concentration (Cmax)
- Terminal half-life (t½)
研究者
研究点 (1)
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