Comparison of Two Liraglutide Formulations in Healthy Subjects

A Randomized, Double-blind, Single-centre, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between the Phase 2 Formulation of Liraglutide at pH 7.7 (Formulation 3) and the Phase 3 Formulation at pH 8.15 (Formulation 4)

This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of the phase 3a formulation of liraglutide at pH 8.15 (formulation 4) and liraglutide at pH 7.7 (formulation 3).

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
• Use of any prescription or non-prescription medication, except for paracetamol and vitamins, as judged by the Investigator