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

Healthy Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01561417
• Other study ID #: NN1007-1744
• Secondary ID: 2005-005379-14
• Status: Completed
• Phase: Phase 1
• First received: March 21, 2012
• Last updated: January 18, 2017
• Start date: April 2006
• Est. completion date: September 2006

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Bleeding Disorder
• Acquired Haemophilia
• Blood Coagulation Disorders
• Congenital Bleeding Disorder
• Congenital FVII Deficiency
• Disease
• Glanzmann's Disease
• Haemophilia A With Inhibitors
• Haemophilia B With Inhibitors
• Healthy
• Hemophilia A
• Hemophilia B
• Hemorrhage
• Hemorrhagic Disorders
• Hemostatic Disorders

Intervention

Drug:
• activated recombinant human factor VII
One single dose administration, injected i.v. (into the vein)
• activated recombinant human factor VII
One single dose administration, injected i.v. (into the vein)

Locations

Country	Name	City	State
France	Novo Nordisk Investigational Site	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

France, 

References & Publications (1)

Bysted BV, Scharling B, Møller T, Hansen BL. A randomized, double-blind trial demonstrating bioequivalence of the current recombinant activated factor VII formulation and a new robust 25 degrees C stable formulation. Haemophilia. 2007 Sep;13(5):527-32. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration versus time curve for FVIIa clot activity
Secondary	The maximum plasma concentration (Cmax)
Secondary	Terminal half-life (t½)

External Links

•   Clinical Trials at Novo Nordisk