NCT01561417

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

A Single-centre, Randomised, Double-blind, Two-way Cross-over Trial Investigating the Bio-equivalence in Healthy Male Subjects of NovoSeven (CP-rFVIIa) and a Formulation of NovoSeven Stable at 25°C (VII25)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Europe. The aim of this trial is to demonstrate bio-equivalence between the marketed activated recombinant human factor VII (NovoSeven®) (CP-rFVIIa) and a new formulation stable at 25°C (VII25).

Conditions

• Acquired Bleeding Disorder
• Acquired Haemophilia
• Congenital Bleeding Disorder
• Congenital FVII Deficiency
• Glanzmann's Disease
• Haemophilia A With Inhibitors
• Haemophilia B With Inhibitors
• Healthy

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2006-04-01
• Primary completion: 2006-09-01
• Completion: 2006-09-01
• First posted: 2012-03-23
• Last updated: 2017-01-19

Locations

1 site across 1 country: France