Bioequivalence of Two Liraglutide Formulations in Healthy Volunteers
- Registration Number
- NCT01515553
- Lead Sponsor
- Novo Nordisk A/S
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Final formulation 4 liraglutide - Formulation 4 liraglutide -
- Primary Outcome Measures
Name Time Method Cmax, maximum concentration Area under the curve (0-t)
- Secondary Outcome Measures
Name Time Method Time to reach maximum (tmax) Terminal elimination half life (t½) Area under the curve (0-infinity) Relative bioavailability Terminal elimination rate constant Adverse events