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

Novo Nordisk A/S28 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

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

Interventions

activated recombinant human factor VIIDRUG

One single dose administration, injected i.v. (into the vein)

activated recombinant human factor VIIDRUG

One single dose administration, injected i.v. (into the vein)

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Area under the plasma concentration versus time curve for FVIIa clot activity

Secondary Outcomes

The maximum plasma concentration (Cmax)

Terminal half-life (t½)