Comparison of Two Insulin Aspart Formulations in Healthy Volunteers

A Single Centre, Randomized, Balanced Double-blind, Cross-Over Trial Investigating the Bioequivalence of a Continuous Subcutaneous Infusion of a Marketed NovoRapid Formulation Containing 100 U/ml and a New NovoRapid Formulation Containing 200 U/ml in Healthy Male Volunteers

This trial is conducted in Africa. The aim of this trial is to determine if a new formulation (U200) of insulin aspart containing 200 U/mL is bioequivalent to that of a marketed insulin aspart formulation (U100).

Inclusion Criteria:

• Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant
• Normal laboratory values, electrocardiogram (ECG), and vital signs unless the investigator considers any abnormality to be clinically irrelevant
• Body mass index (BMI) 18-26 kg/m^2 (both inclusive)
• Weight 60-90 kg
• Non-smoker

Exclusion Criteria:

• Any condition requiring the regular use of any medication
• Known or suspected allergy to the trial product or related products
• Family history of type 1 diabetes mellitus