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)
2 other identifiers
interventional
28
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2006
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 21, 2012
CompletedFirst Posted
Study publicly available on registry
March 23, 2012
CompletedJanuary 19, 2017
January 1, 2017
5 months
March 21, 2012
January 18, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the plasma concentration versus time curve for FVIIa clot activity
Secondary Outcomes (2)
The maximum plasma concentration (Cmax)
Terminal half-life (t½)
Study Arms (2)
CP-rFVIIa
ACTIVE COMPARATORVII25
EXPERIMENTALInterventions
One single dose administration, injected i.v. (into the vein)
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Paris, 75015, France
Related Publications (1)
Bysted BV, Scharling B, Moller 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. doi: 10.1111/j.1365-2516.2007.01516.x.
PMID: 17880439RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2012
First Posted
March 23, 2012
Study Start
April 1, 2006
Primary Completion
September 1, 2006
Study Completion
September 1, 2006
Last Updated
January 19, 2017
Record last verified: 2017-01