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• Status: Withdrawn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