Status:
COMPLETED
Bioequivalence 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 the phase 3a formulation of liraglutide (formulation 4) and the liraglutide formulation planned for phase 3b t...
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
- BMI (Body Mass Index) of 18.0-27.0 kg/m\^2, both inclusive
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 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01515553
Start Date
January 1 2007
End Date
April 1 2007
Last Update
January 13 2015
Active Locations (1)
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1
Lund, Sweden, 221 85