Bioequivalence of Two Liraglutide Formulations in Healthy Volunteers

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: liraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01515553

NN2211-1692

2006-004283-31 (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 (formulation 4) and the liraglutide formulation planned for phase 3b trials (final formulation 4).

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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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22 participants in 2 patient groups

Formulation 4

Experimental group

Treatment:

Drug: liraglutide

Final formulation 4

Experimental group

Treatment:

Drug: liraglutide