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

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Japan. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 (NN-X14Mix50) in healthy Japanese subjects.

Official Title
-----------------
A Randomised, Double-blind, Single-centre, Two-Period Crossover Trial Testing the Bioequivalence of Two Formulations of NN-X14Mix50 in Healthy Japanese Subjects

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Considered generally healthy upon completion of medical history and physical examination, as judged by the Investigator or Sub-Investigator. Body Mass Index (BMI) between 19-29 kg/m^2 (inclusive) Fasting plasma glucose between 3.8-6.0 mmol/L (both inclusive) Exclusion Criteria: Clinically significant abnormal haematology, biochemistry or urinalysis screening tests, as judged by the Investigator or Sub-Investigator Any serious systemic infectious disease that had occurred during the 4 weeks prior to the screening, as judged by the Investigator or Sub-Investigator Any inter-current illness that might affect blood glucose, as judged by the Investigator or Sub-Investigator Hepatitis B or C, or HIV (human immunodeficiency virus) positive Subjects with a first degree relative with diabetes mellitus History of or presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematologic, neurologic, or psychiatric diseases or disorder Subjects who consumed more than 28 units of alcohol per week or who had a significant history of alcoholism or drug/chemical abuse Subjects who smoked more than 5 cigarettes per day Subjects who had taken part in strenuous exercise within 7 days prior to the screening

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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 6-21days<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 6-21days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the insulin aspart concentration-time curve |  |  | 
| Tmax, time to maximum insulin aspart concentration |  |  | 
| MRT, mean residence time |  |  | 
| t½, terminal half-life |  |  |