Comparison of Two Liraglutide Formulations in Healthy Volunteers

Phase 1

Completed

• Conditions: Diabetes; Healthy
• Interventions: Drug: liraglutide

• Registration Number: NCT01508897
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of two formulations of liraglutide.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05-28
• Primary Completion: 2004-06-30
• Study Completion: 2004-06-30
• Study First Submitted: 2012-01-09
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-12
• Status Verified: 2017-02
• Last Update Submitted: 2023-12-29
• Last Update Posted: 2024-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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
• Body Mass Index (BMI) of 18-27 kg/m^2 incl.

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 study, as judged by the investigator
• Impaired renal function
• Uncontrolled treated/untreated hypertension
• Any clinically significant abnormal ECG
• Active hepatitis B and/or active hepatitis C
• Positive HIV (human immunodeficiency virus) antibodies
• History of alcoholism or drug abuse during the last 12 months
• Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
• Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the Investigator
• Excessive consumption of a diet deviating from a normal diet as judged by the Investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Phase 3 formulation	liraglutide	-
Phase 2 formulation	liraglutide	-

Primary Outcome Measures

Name	Time	Method
Cmax, maximum concentration
Area under the Curve (AUC) (0-t)

Secondary Outcome Measures

Name	Time	Method
Adverse events
AUC (0-infinity)
t½, terminal half-life
tmax, time to maximum concentration
Terminal elimination rate constant

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Neu-Ulm, Germany