Comparison of a Blood Clotting Drug (Recombinant Factor XIII) Produced by Two Different Manufacturers in Healthy Male Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

March 31, 2010

Primary Completion Date

July 31, 2010

Study Completion Date

July 31, 2010

Conditions
Congenital Bleeding DisorderCongenital FXIII DeficiencyHealthy
Interventions
DRUG

catridecacog

Single dose of 35 IU/kg body weight recombinant factor XIII (catridecacog) (Novo Nordisk) administered iv (into the vein) followed by a single dose of 35 IU/kg body weight recombinant factor XIII (Avecia) administered iv.

DRUG

recombinant factor XIII

Single dose of 35 IU/kg body weight recombinant factor XIII (Avecia) to be administered iv (into the vein) followed by a single dose of 35 IU/kg body weight recombinant factor XIII (catridecacog) (Novo Nordisk) administered iv.

Trial Locations (1)

HA1 3UJ

Novo Nordisk Investigational Site, Harrow

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY