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Investigating the Bioequivalence of Eptacog Alfa A 6 mg and NovoSeven® in Healthy Male Subjects

NCT02084810 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2014-03-26

No results posted yet for this study

Summary

This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence of eptacog alfa A 6 mg and NovoSeven® in healthy male subjects.

Conditions

  • Congenital Bleeding Disorder
  • Haemophilia A
  • Haemophilia A With Inhibitors
  • Haemophilia B
  • Haemophilia B With Inhibitors
  • Healthy

Interventions

DRUG

activated recombinant human factor VII

All subjects will receive one i.v. (intravenous, into the vein) injection of 90μg/kg. Each subject will be allocated to two treatment periods separated by a wash-out period of a week.

DRUG

eptacog alfa (activated)

All subjects will receive one i.v. injection of 90μg/kg. Each subject will be allocated to two treatment periods separated by a wash-out period of a week.

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
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-07-31
Completion
2014-07-31

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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 NCT02084810 on ClinicalTrials.gov