Clinical Trial: Bioequivalence of NovoSeven® and a NovoSeven® Formulation Stable at Room Temperature in Healthy Male Subjects
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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°
Brief 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).
Detailed Summary:
Sponsor: Novo Nordisk A/S
Current Primary Outcome: Area under the plasma concentration versus time curve for FVIIa clot activity
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The maximum plasma concentration (Cmax)
- Terminal half-life (t½)
Original Secondary Outcome: Same as current
Information By: Novo Nordisk A/S
Dates:
Date Received: March 21, 2012
Date Started: April 2006
Date Completion:
Last Updated: January 18, 2017
Last Verified: January 2017
