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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

March 21, 2012
June 28, 2012
April 2006
September 2006   (final data collection date for primary outcome measure)
Area under the plasma concentration versus time curve for FVIIa clot activity [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01561417 on ClinicalTrials.gov Archive Site
  • The maximum plasma concentration (Cmax) [ Designated as safety issue: No ]
  • Terminal half-life (t½) [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Bioequivalence of NovoSeven® and a NovoSeven® Formulation Stable at Room Temperature in Healthy Male Subjects
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)

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).
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • 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
One single dose administration, injected i.v. (into the vein)
  • Active Comparator: CP-rFVIIa
    Intervention: Drug: activated recombinant human factor VII
  • Experimental: VII25
    Intervention: Drug: activated recombinant human factor VII
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
September 2006
September 2006   (final data collection date for primary outcome measure)

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
Male
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01561417
NN1007-1744, 2005-005379-14
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
Not Provided
Study Director: Birgitte Scharling Novo Nordisk
Novo Nordisk
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP