Overview

Comparison of a Blood Clotting Drug (Recombinant Factor XIII) Produced by Two Different Manufacturers in Healthy Male Subjects

Status:
Completed
Trial end date:
2010-07-01
Target enrollment:
0
Participant gender:
Male
Summary
This trial is conducted in Europe. The aim of this clinical trial is to compare the metabolism of a blood-clotting drug (recombinant Factor XIII)) produced by two different manufacturers (Novo Nordisk and Avecia) in healthy male volunteers.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Novo Nordisk A/S
Criteria
Inclusion Criteria:

- Body Mass Index (BMI) between 18.5 and 30 kg/m2

- Good general health based on assessment of medical history, physical examination, ECG
(electrocardiogram), and clinical laboratory data at screening, as judged by the
physician

- Non-smokers

Exclusion Criteria:

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

- Blood transfusion within 3 months of trial start

- Positive for hepatitis B or C infection

- Positive for Human Immunodeficiency Virus (HIV) infection

- Excessive consumption of a diet deviating from a normal diet as judged by the
physician

- Blood or plasma donation within the last 3 months prior to trial start

- Subjects with any history of migraine