跳至主要内容
临床试验/NCT01082406
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)

Novo Nordisk A/S1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2010年3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
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

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

申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验