Investigating the Bioequivalence of Eptacog Alfa A 6 mg and NovoSeven® in Healthy Male Subjects

PHASE1WithdrawnINTERVENTIONAL
0
Timeline

Start Date

March 31, 2014

Primary Completion Date

July 31, 2014

Study Completion Date

July 31, 2014

Conditions
Congenital Bleeding DisorderHaemophilia AHaemophilia A With InhibitorsHaemophilia BHaemophilia B With InhibitorsHealthy
Interventions
DRUG

activated recombinant human factor VII

"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."

DRUG

eptacog alfa (activated)

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.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY