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

Study Overview
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Brief Summary
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This trial is conducted in Europe. 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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Single-Centre, Randomised, Balanced, Double- Blind, Cross-Over Trial Investigating the Bioequivalence of Formulation 2 and Formulation 4 of Biphasic Insulin Aspart 50 in Healthy Male Subjects

Conditions
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Diabetes, Healthy

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 19.0-30.0 kg/m^2 Glycohemoglobin (HbA1c) within laboratory normal range Non-smokers Exclusion Criteria: The receipt of any investigational drug within the last 3 months prior to this trial. Clinically significant abnormal haematology, biochemistry, urinalysis or ECG (electrocardiogram) screening tests, as judged by the investigator Liver enzyme values (ALAT and ASAT) exceeding 2 times the upper reference limit according to the local laboratory History of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive urine drug screen and breath alcohol screen) HIV (human immunodeficiency virus), Hepatitis B or C positive Subjects with a first-degree relative with diabetes mellitus A history of multiple and/or severe allergies to drugs or foods or a history of anaphylactic reactions

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 administrated subcutaneously (s.c., under the skin) on two separate dosing visits. A wash-out period of 6-12 days will take place between dosing visits<br>|
| Experimental: Formulation B<br> | Drug: biphasic insulin aspart 50<br>* A single dose administrated subcutaneously (s.c., under the skin) on two separate dosing visits. A wash-out period of 6-12 days will take place between dosing visits<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, time to maximum insulin aspart concentration |  |  | 
| Area under the insulin aspart curve |  |  | 
| Mean residence time (MRT) |  |  | 
| t½, terminal half-life |  |  | 
| Incidence of hypoglycaemic events |  |  |