Lund, 221 85, Sweden
NCT Number: NCT01515553
Bioequivalence of Two Liraglutide Formulations in Healthy Volunteers
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).
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Notify MeKey information
Conditions
Age range
18 year–50 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
liraglutide
DrugTwo single doses of 0.72 mg liraglutide administered subcutaneously on two different dosing occasions separated by a wash-out period
Primary outcomes
-
Area under the curve (0-t)
-
Cmax, maximum concentration
Secondary outcomes
-
Area under the curve (0-infinity)
-
Relative bioavailability
-
Time to reach maximum (tmax)
-
Terminal elimination half life (t½)
-
Terminal elimination rate constant
-
Adverse events
Sponsors and collaborators
Lead sponsor
Novo Nordisk A/S
Industry
Registry information
Official study title
A Randomized, Double-blind, Single-centre, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between the Phase 3a Formulation of Liraglutide (Formulation 4) and the Planned Phase 3b Formulation (Final Formulation 4)
Important dates
- Study start
- 2007
- Primary completion
- 2007
- Study completion
- 2007
- First posted
- Jan 24, 2012
- Registry last updated
- Jan 13, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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