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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy, Diabetes

Intervention / Treatment
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* Drug: biphasic insulin aspart 50


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Formulation A<br> | Drug: biphasic insulin aspart 50<br>* A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-12 days<br>|
| Experimental: Formulation B<br> | Drug: biphasic insulin aspart 50<br>* A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-12 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the insulin aspart curve in the interval from 0-16 hours |  |  | 
| Cmax, maximum insulin aspart concentration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tmax, the time to maximum insulin aspart concentration |  |  | 
| Area under the insulin aspart curve |  |  | 
| Mean residence time (MRT) |  |  | 
| The area under the glucose infusion rate curve |  |  | 
| GIRmax, maximum glucose infusion rate value |  |  | 
| tGIRmax, time to maximum glucose infusion rate value |  |  | 
| Adverse events |  |  |