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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Acquired Haemophilia

Healthy

Haemophilia B With Inhibitors

Haemophilia A With Inhibitors

Glanzmann's Disease

Congenital Bleeding Disorder

Congenital FVII Deficiency

Acquired Bleeding Disorder

Treatments

Drug: activated recombinant human factor VII

Study type

Interventional

Funder types

Industry

Identifiers

NCT01561417

NN1007-1744

2005-005379-14 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment

28 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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