Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Male Subjects

A Single-Centre, Randomised, Balanced, Double-Blind, Cross-Over Trial Investigating the Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Male Subjects

This trial is conducted in Africa. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 in healthy male subjects.

Inclusion Criteria:

• Considered generally healthy upon completion of medical history and physical examination, as judged by the investigator
• Body Mass Index (BMI) between 19-29 kg/m^2 (both inclusive)
• Minimum body weight of 65 kg
• Fasting blood glucose between 3.8-6.0 mmol/L
• Glycohemoglobin (HbA1c) below 6.4 %
• Non-smokers

Exclusion Criteria:

• Clinically significant abnormal hematology, biochemistry, urinalysis or ECG (electrocardiogram) screening tests, as judged by the investigator
• A history of any illness that, in the opinion of the Investigator and/or Sponsor, might confound the results of the study or pose additional risk in administering the investigational product to the subject
• History of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive drug/alcohol abuse screen)
• Hepatitis B or C
• Subjects with a first-degree relative with diabetes mellitus
• Known or suspected allergy to trial product or related products
• Smoking during the past three months