Trials / Withdrawn
WithdrawnNCT02084810
Investigating the Bioequivalence of Eptacog Alfa A 6 mg and NovoSeven® in Healthy Male Subjects
A Single Centre, Randomised, Double-blind, Two-way Crossover Trial in Healthy Male Subjects Investigating the Bioequivalence of Eptacog Alfa A 6 mg and NovoSeven®
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2014-07-01
- Completion
- 2014-07-01
- First posted
- 2014-03-12
- Last updated
- 2014-03-26
Source: ClinicalTrials.gov record NCT02084810. Inclusion in this directory is not an endorsement.