Overview

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

Status:
Withdrawn
Trial end date:
2014-07-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Novo Nordisk A/S
Criteria
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

Exclusion Criteria:

- Known history of thromboembolic event(s) or potential thromboembolic risk as judged by
the investigator