Comparison of Two Formulations of Biphasic Insulin Aspart 70

A Randomised, Double Blind, Single Centre, Three Period Crossover Trial Testing the Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 and Characterising the Pharmacokinetics of Biphasic Insulin Aspart 50 in Healthy Male Subjects

This trial is conducted in Europe. The aim of this trial is to compare two formulations of biphasic insulin aspart 70 and characterise the pharmacokinetics of biphasic insulin aspart 50 and biphasic insulin aspart 70 in healthy male subjects.

Each subject participated in three treatment periods, and were randomly assigned to each of the six treatment sequences in varying order

Inclusion Criteria:

• Caucasian
• Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
• Body mass index (BMI) between 19-27 kg/m^2
• Fasting plasma glucose between 3.8-6.0 mmol/L

Exclusion Criteria:

• Participation in any other clinical trial involving other investigational products within the last three months
• Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator
• Any serious systemic infectious disease that occurred in the 4 weeks prior to the first dose of test drug