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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2006-09-30

Brief Summary

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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).

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CP-rFVIIa

Group Type ACTIVE_COMPARATOR

activated recombinant human factor VII

Intervention Type DRUG

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

VII25

Group Type EXPERIMENTAL

activated recombinant human factor VII

Intervention Type DRUG

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

Interventions

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activated recombinant human factor VII

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

Intervention Type DRUG

activated recombinant human factor VII

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No