Pharmacokinetics of Insulin Detemir in Healthy Chinese Male Subjects

Study Overview
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Brief Summary
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This trial is conducted in Asia. The aim of this trial is to investigate the pharmacokinetics after a single dose of insulin detemir in healthy Chinese male subjects.

Official Title
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A Single Centre, Randomised, Double-blind, Three-period Cross-over Trial to Investigate the 24-hour Pharmacokinetics After Single Dose of Insulin Detemir in Healthy Chinese Male Subjects

Conditions
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Diabetes, Healthy

Intervention / Treatment
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* Drug: insulin detemir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) between 18 and 25 kg/m^2 (both inclusive) Fasting plasma glucose maximum 6 mmol/L Non-smoker Considered generally healthy upon completion of medical history, physical examination and laboratory assessments, as judged by the Investigator Exclusion Criteria: Known or suspected allergy to trial product(s) or related products Previous participation in this trial. Participation is defined as randomisation Receipt of any investigational drug within the last three months prior to this trial History of alcohol or drug abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: IDet 0.2 U/kg<br> | Drug: insulin detemir<br>* Each subject will be randomly allocated to an insulin detemir dosing sequence. Three doses of insulin detemir (0.2, 0.4 or 0.8 U/kg) will be administered on three inconsecutive days with a wash-out period between each dosing. Injected subcutaneously (s.c., under the skin)<br>|
| Experimental: IDet 0.4 U/kg<br> | Drug: insulin detemir<br>* Each subject will be randomly allocated to an insulin detemir dosing sequence. Three doses of insulin detemir (0.2, 0.4 or 0.8 U/kg) will be administered on three inconsecutive days with a wash-out period between each dosing. Injected subcutaneously (s.c., under the skin)<br>|
| Experimental: IDet 0.8 U/kg<br> | Drug: insulin detemir<br>* Each subject will be randomly allocated to an insulin detemir dosing sequence. Three doses of insulin detemir (0.2, 0.4 or 0.8 U/kg) will be administered on three inconsecutive days with a wash-out period between each dosing. Injected 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 detemir concentration curve |  | from time zero to 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the insulin detemir concentration curve |  |  | 
| Maximum serum insulin detemir concentration |  |  | 
| Time to maximum serum insulin detemir concentration |  |  | 
| Mean residence time (MRT) |  |  | 
| Terminal half-life |  |  | 
| Insulin detemir clearance |  |  | 
| Adverse events |  |  |