Pharmacokinetics of Biphasic Insulin Aspart 50 and 70 in Japanese Healthy Volunteers

Study Overview
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Brief Summary
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This trial is conducted in Japan. The aim of this trial is to investigate the pharmacokinetics of biphasic insulin aspart 50 (NN-X14Mix50) and biphasic insulin aspart 70 (NN-X14Mix70) in Japanese healthy volunteers.

Official Title
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A Randomised, Open-labelled, Single-centre, Two-period Crossover Trial Characterizing the Pharmacokinetics and Pharmacodynamics of NN-X14Mix50 and NN-X14Mix70 in Healthy Male Subjects

Conditions
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Diabetes, Healthy

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Japanese Body Mass Index (BMI) of 19-27 kg/m^2 (both inclusive) Fasting blood glucose between 3.8-6 mmol/L (68.4-108.0 mg/dL) (both inclusive Considered generally healthy upon completion of medical history and physical examination, as judged by the Investigator or Sub-Investigator Exclusion Criteria: Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator or Sub-Investigator(s) Any serious systemic infectious disease that occurred during the 4 weeks prior to the screening, as judged by the Investigator or Sub-Investigator Any inter-current illness that may affect blood glucose, as judged by the Investigator or Sub-Investigator Hepatitis B or C, or HIV (human immunodeficiency virus) Use of prescription drugs within 2 weeks preceding the screening Use of non-prescription drugs, except routine vitamins or drugs that may not Blood donation of more than 1150 mL within the last 12 months Subjects with a first degree relative with diabetes mellitus History of or presence of diabetes History of or presence of cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematologic, neurologic, or psychiatric diseases or disorder Previous history of serious allergy or anaphylactic reaction Subjects who consume more than 28 units of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse Subjects who smoke more than 5 cigarettes per day

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment period 1<br> | Drug: biphasic insulin aspart 50<br>* A single dose of 0.08 U/kg body weight, administered subcutaneously (s.c., under the skin) on two dosing visits in random order separated by 6-12 days<br>Drug: biphasic insulin aspart 70<br>* A single dose of 0.08 U/kg body weight, administered subcutaneously (s.c., under the skin) on two dosing visits in random order separated by 6-12 days<br>|
| Experimental: Treatment period 2<br> | Drug: biphasic insulin aspart 50<br>* A single dose of 0.08 U/kg body weight, administered subcutaneously (s.c., under the skin) on two dosing visits in random order separated by 6-12 days<br>Drug: biphasic insulin aspart 70<br>* A single dose of 0.08 U/kg body weight, administered subcutaneously (s.c., under the skin) on two dosing visits in random order separated by 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 to 24 hours (BIAsp 70) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax, maximum insulin aspart concentration |  |  | 
| tmax, time to maximum insulin aspart concentration |  |  | 
| t½, terminal elimination half life |  |  | 
| Mean residence time (MRT) |  |  | 
| Area under the curve from time 0 to infinity (0-∞) |  |  | 
| Area under the insulin aspart curve in the interval from 0 to 24 hours (BIAsp 50) |  |  | 
| Adverse events |  |  |