Diabetes, Healthy
Conditions
Brief summary
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.
Interventions
DRUGinsulin detemir
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)
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the insulin detemir concentration curve | from time zero to 24 hour |
Secondary
| Measure | Time frame |
|---|---|
| Maximum serum insulin detemir concentration | — |
| Time to maximum serum insulin detemir concentration | — |
| Mean residence time (MRT) | — |
| Area under the insulin detemir concentration curve | — |
| Insulin detemir clearance | — |
| Adverse events | — |
| Terminal half-life | — |
Countries
China
Outcome results
None listed