Diabetes, Healthy
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of the phase 3a formulation of liraglutide (formulation 4) and the liraglutide formulation planned for phase 3b trials (final formulation 4).
Interventions
DRUGliraglutide
Two single doses of 0.72 mg liraglutide administered subcutaneously on two different dosing occasions separated by a wash-out period
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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) of 18.0-27.0 kg/m\^2, both inclusive
Exclusion criteria
* 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 * Any clinically significant abnormal ECG, as judged by the Investigator * Active hepatitis B and/or active hepatitis C * Positive human immunodeficiency virus (HIV) antibodies * Known or suspected allergy to trial product(s) or related products * Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures * History of alcoholism or drug abuse, or positive results in alcohol or drug screens * Smoking of more than 5 cigarettes per day, or the equivalent for other tobacco products * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve (0-t) | — |
| Cmax, maximum concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under the curve (0-infinity) | — |
| Relative bioavailability | — |
| Time to reach maximum (tmax) | — |
| Terminal elimination half life (t½) | — |
| Terminal elimination rate constant | — |
| Adverse events | — |
Countries
Sweden
Outcome results
None listed