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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01561417
First received: March 21, 2012
Last updated: June 28, 2012
Last verified: June 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Acquired Bleeding Disorder
Acquired Haemophilia
Congenital Bleeding Disorder
Congenital FVII Deficiency
Glanzmann's Disease
Haemophilia A With Inhibitors
Haemophilia B With Inhibitors
Healthy
 Drug: activated recombinant human factor VII
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Area under the plasma concentration versus time curve for FVIIa clot activity [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The maximum plasma concentration (Cmax) [ Designated as safety issue: No ]
  • Terminal half-life (t½) [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: April 2006
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CP-rFVIIa Drug: activated recombinant human factor VII
One single dose administration, injected i.v. (into the vein)
Experimental: VII25 Drug: activated recombinant human factor VII
One single dose administration, injected i.v. (into the vein)

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01561417

Locations
France
Paris, France, 75015
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Birgitte Scharling Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01561417     History of Changes
Other Study ID Numbers: NN1007-1744, 2005-005379-14
Study First Received: March 21, 2012
Last Updated: June 28, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Hemophilia B
Hemophilia A
Hemorrhage
Thrombasthenia
Hematologic Diseases
 Vascular Diseases
Cardiovascular Diseases
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Pathologic Processes
Blood Platelet Disorders

ClinicalTrials.gov processed this record on June 18, 2013