Comparison of Two Liraglutide Formulations in Healthy Subjects

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Healthy

Diabetes

Treatments

Drug: liraglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01515579

NN2211-1693

2005-005948-68 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment

22 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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