This trial is conducted in Japan. The aim of this clinical trial is to investigate the pharmacokinetics (the effect of the investigated drug on the body) and safety of turoctocog alfa (recombinant factor VIII (N8)) in Japanese subjects with haemophilia A.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Subjects will receive recombinant factor VIII (N8) at a dose of 50 +/- 5 IU/kg body weight. Intravenous administration as a single bolus injection.
Novo Nordisk Investigational Site
Itabashi-ku, Tokyo, Japan
Novo Nordisk Investigational Site
Kashihara-shi, Nara, Japan
Novo Nordisk Investigational Site
Maebashi-shi, Gunma, Japan
Novo Nordisk Investigational Site
Shinjuku-ku, Tokyo, Japan
Area under the curve
Time frame: Infusion, 30 minutes
Incremental recovery
Time frame: Infusion, 30 minutes
In vivo t1/2
Time frame: Infusion, 30 minutes
Total clearance (CL)
Time frame: Infusion, 30 minutes
Maximal concentration
Time frame: at 15 minutes
Area under the curve
Time frame: from time zero to last
Number of adverse events
Time frame: from day -1 to day 3 (end of trial)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novo Nordisk Investigational Site
Shizuoka-shi, Shizuoka, Japan
Novo Nordisk Investigational Site
Suginami-ku, Tokyo, Japan