Bioequivalence of NovoSeven® and a NovoSeven® Formulation Stable at Room Temperature in Healthy Male Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

April 30, 2006

Primary Completion Date

September 30, 2006

Study Completion Date

September 30, 2006

Conditions
Acquired Bleeding DisorderAcquired HaemophiliaCongenital Bleeding DisorderCongenital FVII DeficiencyGlanzmann's DiseaseHaemophilia A With InhibitorsHaemophilia B With InhibitorsHealthy
Interventions
DRUG

activated recombinant human factor VII

One single dose administration, injected i.v. (into the vein)

DRUG

activated recombinant human factor VII

One single dose administration, injected i.v. (into the vein)

Trial Locations (1)

75015

Novo Nordisk Investigational Site, Paris

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY