Comparison of Two Liraglutide Formulations in Healthy Volunteers

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Healthy

Diabetes

Treatments

Drug: liraglutide

Study type

Interventional

Funder types

Industry

Identifiers

NN2211-1331

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of two formulations of liraglutide.

Enrollment

22 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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
Body Mass Index (BMI) of 18-27 kg/m^2 incl.

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 study, as judged by the investigator
Impaired renal function
Uncontrolled treated/untreated hypertension
Any clinically significant abnormal ECG
Active hepatitis B and/or active hepatitis C
Positive HIV (human immunodeficiency virus) antibodies
History of alcoholism or drug abuse during the last 12 months
Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the Investigator
Excessive consumption of a diet deviating from a normal diet as judged by the Investigator