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