Comparison of Two Liraglutide Formulations in Healthy Volunteers

A Randomized, Single-blind, Single-centre, Two-period, Cross-over Trial Investigating the Bioequivalence Between Completed Phase 2 and Planned Phase 3 Formulations of Liraglutide in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01508897

Enrollment

Registered

2012-01-12

Start date

2004-05-28

Completion date

2004-06-30

Last updated

2024-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Healthy

Brief summary

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

Interventions

DRUGliraglutide

Single dose administered as subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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 * 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

Design outcomes

Primary

Measure	Time frame
Area under the Curve (AUC) (0-t)	—
Cmax, maximum concentration	—

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026