Diabetes, Healthy
Conditions
Brief summary
This trial is conducted in Europe. The aim of the trial is to compare the pharmacokinetic properties (the exposure of the trial drug in the body) of faster-acting insulin aspart (FIAsp) after different injection regions and routes of administration in healthy subjects.
Interventions
DRUGFaster-acting insulin aspart
Drug: insulin aspart (faster acting insulin aspart) Subjects will receive five single dose level of faster acting insulin aspart. Three single dose s.c under the skin (abdomen, deltoid/upper arm, thigh), one single dose i.m. (intramuscularly, into the muscle) and one single dose i.v. (intravenously, into the vein)
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female, aged 18-64 years both inclusive at the time of signing informed consent * Considered generally healthy upon completion of medical history, physical examination,analysis of laboratory safety variables, vital signs and ECG (electrocardiogram), as judged by the investigator * Body mass index 20.0-28.0 kg/m\^2 (both inclusive)
Exclusion criteria
* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening * Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily) * Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the serum insulin aspart concentration-time curve (only for subcutaneous administration) | From 0 to 12 hours |
Secondary
| Measure | Time frame |
|---|---|
| Area under the serum insulin aspart concentration-time curve (only for intramuscular administration) | From 0 to 12 hours |
| Maximum observed serum insulin aspart concentration (only for subcutaneous and intramuscular administration) | From 0 to 12 hours |
Countries
Germany
Outcome results
None listed