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

A Single Centre, Randomised, Double-blind, Cross-over Trial in Healthy Male Subjects Investigating Bioequivalence and Pharmacokinetics of rFXIII (Avecia DS) to rFXIII (Novo Nordisk DS)

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.

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