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)

Novo Nordisk A/S1 site in 1 country28 target enrollmentApril 2006

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

Interventionsactivated recombinant human factor VII

Drugsactivated recombinant human factor VII

Overview

Phase: Phase 1
Intervention: activated recombinant human factor VII
Conditions: Acquired Bleeding Disorder
Sponsor: Novo Nordisk A/S
Enrollment: 28
Locations: 1
Primary Endpoint: Area under the plasma concentration versus time curve for FVIIa clot activity
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

April 2006

End Date

September 2006

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility 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