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

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S

Criteria

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