Comparison of Two Formulations of Biphasic Insulin Aspart 70

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 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.

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

Official Title
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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

Conditions
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Diabetes, Healthy

Intervention / Treatment
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* Drug: biphasic insulin aspart 70
* Drug: biphasic insulin aspart 70
* Drug: biphasic insulin aspart 50


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

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: BIAsp 70 clinical trial formulation<br> | Drug: biphasic insulin aspart 70<br>* A single dose administrated subcutaneously (s.c., under the skin)<br>|
| Experimental: BIAsp 70 final formulation<br> | Drug: biphasic insulin aspart 70<br>* A single dose administrated subcutaneously (s.c., under the skin)<br>|
| Experimental: BIAsp 50 final formulation<br> | Drug: biphasic insulin aspart 50<br>* A single dose administrated subcutaneously (s.c., under the skin)<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 0-24 hours |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax, maximum insulin aspart concentration |  |  | 
| tmax, the time to maximum insulin aspart concentration |  |  | 
| t½, terminal half-life |  |  | 
| Cmin, minimum glucose concentration |  |  | 
| tmin, time to minimum concentration |  |  |