Status:
COMPLETED
Comparison of Two Liraglutide Formulations in Healthy Volunteers
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of two formulations of liraglutide.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 28 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2004
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01508897
Start Date
May 28 2004
End Date
June 30 2004
Last Update
January 2 2024
Active Locations (1)
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1
Novo Nordisk Investigational Site
Neu-Ulm, Germany, 89231