Brief Title
Investigating the Bioequivalence of Eptacog Alfa A 6 mg and NovoSeven® in Healthy Male Subjects
Official Title
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®
Brief 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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Area under the curve
Secondary Outcome
Frequency of adverse events (including serious adverse events)
Condition
Congenital Bleeding Disorder
Intervention
activated recombinant human factor VII
Study Arms / Comparison Groups
NovoSeven®
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
0
Start Date
March 2014
Completion Date
July 2014
Primary Completion Date
July 2014
Eligibility 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
Gender
Male
Ages
18 Years - 55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Global Clinical Registry (GCR, 1452), ,
Administrative Informations
NCT ID
NCT02084810
Organization ID
NN7777-4087
Secondary IDs
2013-003163-63
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S
Verification Date
March 2014