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)

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).

Inclusion Criteria:

• Caucasian
• Body Mass Index (BMI) between 18 and 27 kg/m^2, both inclusive
• Good health as indicated by medical history, physical examination including vital signs and ECG, and clinical laboratory test results
• Smoke less than 10 cigarettes (or equivalent) per day
• Capable of giving written Informed Consent (IC)

Exclusion Criteria:

• Evidence of clinically relevant pathology or potential thromboembolic risk based on medical and/or family history as judged by the Investigator
• Known history of atherosclerosis, arteriosclerosis, thromboembolic events or known high levels of Troponin I
• Known or suspected allergy to activated recombinant human factor VII or related products or any of the components of the formulation
• Overt bleeding, including from gastrointestinal tract
• Hepatitis (B or C) infection
• HIV (human immunodeficiency virus) infection