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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
All subjects will receive one i.v. (intravenous, into the vein) injection of 90μg/kg. Each subject will be allocated to two treatment periods separated by a wash-out period of a week.
All subjects will receive one i.v. injection of 90μg/kg. Each subject will be allocated to two treatment periods separated by a wash-out period of a week.
Area under the curve
Time frame: After a single i.v. injection based on FVIIa activity assessments up to 36 hours post dose
Maximum concentration
Time frame: After a single i.v. injection based on FVIIa activity assessments up to 36 hours post dose
Frequency of adverse events (including serious adverse events)
Time frame: Assessed up to 7 weeks following first trial product administration
Incidence of antibodies
Time frame: Assessed up to 7 weeks following first trial product administration
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