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Clinical Trials/NCT01561417
NCT01561417CompletedPhase 1

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)

Novo Nordisk A/S1 site in 1 country28 target enrollmentStarted: April 2006Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
28
Locations
1
Primary Endpoint
Area under the plasma concentration versus time curve for FVIIa clot activity
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
No

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

Arms & Interventions

CP-rFVIIa

Active Comparator

Intervention: activated recombinant human factor VII (Drug)

VII25

Experimental

Intervention: activated recombinant human factor VII (Drug)

Outcomes

Primary Outcomes

Area under the plasma concentration versus time curve for FVIIa clot activity

Secondary Outcomes

  • The maximum plasma concentration (Cmax)
  • Terminal half-life (t½)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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