临床试验/NCT02084810

NCT02084810撤回1 期

A Single Centre, Randomised, Double-blind, Two-way Crossover Trial in Healthy Male Subjects Investigating the Bioequivalence of Eptacog Alfa A 6 mg and NovoSeven®

Novo Nordisk A/S0 个研究点开始时间: 2014年3月最近更新: 2014年3月26日

适应症

干预措施

试验速览

阶段: 1 期
状态: 撤回
发起方: Novo Nordisk A/S
主要终点: Area under the curve

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence of eptacog alfa A 6 mg and NovoSeven® in healthy male 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 55 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Male, age 18-55 years, both inclusive, at the time of signing informed consent
•Body Mass Index (BMI) 18.5-30 kg/m^2, both inclusive
•Good general health based on assessment of medical history, vital signs, physical examination, ECG (electrocardiogram), and laboratory data at screening, as judged by the investigator

排除标准

•Known history of thromboembolic event(s) or potential thromboembolic risk as judged by the investigator

研究组 & 干预措施

NovoSeven®

Active Comparator

干预措施: activated recombinant human factor VII (Drug)

Eptacog alfa A 6 mg

Experimental

干预措施: eptacog alfa (activated) (Drug)

结局指标

主要结局

Area under the curve

时间窗: After a single i.v. injection based on FVIIa activity assessments up to 36 hours post dose

Maximum concentration

时间窗: After a single i.v. injection based on FVIIa activity assessments up to 36 hours post dose

次要结局

Frequency of adverse events (including serious adverse events)(Assessed up to 7 weeks following first trial product administration)
Incidence of antibodies(Assessed up to 7 weeks following first trial product administration)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

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