NCT01082406已完成1 期
A Single Centre, Randomised, Double-blind, Cross-over Trial in Healthy Male Subjects Investigating Bioequivalence and Pharmacokinetics of rFXIII (Avecia DS) to rFXIII (Novo Nordisk DS)
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
- 51
- 试验地点
- 1
- 主要终点
- Plasma concentration-time curve (Area under Curve 0-28 days) for factor XIII activityfor both drug substances measured by the Berichrom® assay
研究概览
简要总结
This trial is conducted in Europe. The aim of this clinical trial is to compare the metabolism of a blood-clotting drug (recombinant Factor XIII)) produced by two different manufacturers (Novo Nordisk and Avecia) in healthy male volunteers.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) between 18.5 and 30 kg/m2
- •Good general health based on assessment of medical history, physical examination, ECG (electrocardiogram), and clinical laboratory data at screening, as judged by the physician
- •Non-smokers
排除标准
- •Known history of thromboembolic event(s) or potential thromboembolic risk as judged by the physician
- •Blood transfusion within 3 months of trial start
- •Positive for hepatitis B or C infection
- •Positive for Human Immunodeficiency Virus (HIV) infection
- •Excessive consumption of a diet deviating from a normal diet as judged by the physician
- •Blood or plasma donation within the last 3 months prior to trial start
- •Subjects with any history of migraine
研究组 & 干预措施
Trial part 1
Experimental
干预措施: catridecacog (Drug)
Trial part 2
Experimental
干预措施: recombinant factor XIII (Drug)
结局指标
主要结局
Plasma concentration-time curve (Area under Curve 0-28 days) for factor XIII activityfor both drug substances measured by the Berichrom® assay
时间窗: after 4 weeks of treatment
次要结局
- Number of adverse events (serious and non-serious)(over 8 weeks of treatment)
研究者
研究点 (1)
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