Bioequivalence of Two Liraglutide Formulations in Healthy Volunteers

Study Overview
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Brief Summary
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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).

Official Title
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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)

Conditions
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Diabetes, Healthy

Intervention / Treatment
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* Drug: liraglutide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Formulation 4<br> | Drug: liraglutide<br>* Two single doses of 0.72 mg liraglutide administered subcutaneously on two different dosing occasions separated by a wash-out period<br>|
| Experimental: Final formulation 4<br> | Drug: liraglutide<br>* Two single doses of 0.72 mg liraglutide administered subcutaneously on two different dosing occasions separated by a wash-out period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (0-t) |  |  | 
| Cmax, maximum concentration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (0-infinity) |  |  | 
| Relative bioavailability |  |  | 
| Time to reach maximum (tmax) |  |  | 
| Terminal elimination half life (t½) |  |  | 
| Terminal elimination rate constant |  |  | 
| Adverse events |  |  |