Comparison of Two Liraglutide Formulations in Healthy Subjects

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Liraglutide

Criteria

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