Diabetes, Healthy
Conditions
Brief summary
This trial is conducted in Europe. the aim of this trial is to compare the pharmacokinetic profile of liraglutide between administrations in the thigh versus the abdomen and between administrations in the upper arm versus the abdomen.
Interventions
DRUGliraglutide
Single dose of 0.60 mg administered subcutaneously in three different injection sites on three separate dosing visits
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 50 Years
Healthy volunteers
No
Inclusion criteria
* Healthy * Good general health as judged by the Investigator based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs and blood and urinary laboratory assessments * BMI (Body Mass Index): 18.5-27.5 kg/m\^2, both inclusive
Exclusion criteria
* Known or suspected allergy to trial product(s) or related products * Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods as required by local law or practice * The receipt of any investigational drug within 3 months prior to this trial * History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the Investigator * Impaired renal function * Active hepatitis B and/or active hepatitis C * Positive human immunodeficiency virus (HIV) antibodies * Use of any prescription or non-prescription medication, except for paracetamol and vitamins * History of alcoholism or drug abuse during the last 12 months. * Smoking * Habitual excessive consumption of methylxanthine-containing (theophylline, caffeine or theobromine) beverages and foods (coffee, tea, soft drinks such as red bull, cola, chocolate) as judged by the Investigator * Excessive consumption of a diet deviating from a normal diet as judged by the Investigator * Blood donation within the last 3 months * Plasma donation within the last month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the Curve (AUC) of liraglutide for each injection site | — |
Secondary
| Measure | Time frame |
|---|---|
| Cmax, maximum concentration | — |
| tmax, time to maximum concentration | — |
| t½, terminal half-life | — |
| AUC | — |
| Relative Bioavailability | — |
| Adverse events | — |
| Terminal elimination rate constant | — |
Countries
Germany
Outcome results
None listed