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

NCT01561417 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2017-01-19

No results posted yet for this study

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).

Conditions

  • Acquired Bleeding Disorder
  • Acquired Haemophilia
  • Congenital Bleeding Disorder
  • Congenital FVII Deficiency
  • Glanzmann's Disease
  • Haemophilia A With Inhibitors
  • Haemophilia B With Inhibitors
  • Healthy

Interventions

DRUG

activated recombinant human factor VII

One single dose administration, injected i.v. (into the vein)

DRUG

activated recombinant human factor VII

One single dose administration, injected i.v. (into the vein)

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2006-09-30
Completion
2006-09-30

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01561417 on ClinicalTrials.gov