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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NovoSeven®

Group Type ACTIVE_COMPARATOR

activated recombinant human factor VII

Intervention Type DRUG

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.

Eptacog alfa A 6 mg

Group Type EXPERIMENTAL

eptacog alfa (activated)

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male, age 18-55 years, both inclusive, at the time of signing informed consent
* Body Mass Index (BMI) 18.5-30 kg/m\^2, both inclusive
* Good general health based on assessment of medical history, vital signs, physical examination, ECG (electrocardiogram), and laboratory data at screening, as judged by the investigator