Comparison of Two Liraglutide Formulations in Healthy Volunteers

• Status: Completed
• Trial end date: 2004-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Liraglutide

Criteria

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