This trial is conducted in Europe. The aim of this trial is to determine the pharmacokinetics of activated recombinant human factor VII (NovoSeven®) in haemophiliac patients in a non-bleeding state.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
A single bolus dose is administered. Injected intravenously
A random order of a low/high dose of single dose is administered during two PK-assessment periods separated by a washout period of 48 hours to one month. Injected intravenously
Novo Nordisk Investigational Site
Bremen, Germany
Novo Nordisk Investigational Site
Frankfurt, Germany
Novo Nordisk Investigational Site
Athens, Greece
Novo Nordisk Investigational Site
Florence, Italy
Area under the concentration curve from 0-12 hours
CL, the total body clearance
Cmax, the maximum concentration
tmax, the time to maximum concentration
t1/2, the terminal half-life
Area under the concentration curve from time 0-infinity
Vss, the apparent volume of distribution at steady state
Adverse events
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novo Nordisk Investigational Site
Milan, Italy
Novo Nordisk Investigational Site
Madrid, Spain
Novo Nordisk Investigational Site
London, United Kingdom
Novo Nordisk Investigational Site
Oxford, United Kingdom