Comparison of Two Liraglutide Formulations in Healthy Subjects

A Randomized, Double-blind, Single-centre, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between the Phase 2 Formulation of Liraglutide at pH 7.7 (Formulation 3) and the Phase 3 Formulation at pH 8.15 (Formulation 4)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01515579

Enrollment

Registered

2012-01-24

Start date

2006-04-30

Completion date

2006-06-30

Last updated

2015-01-30

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 the phase 3a formulation of liraglutide at pH 8.15 (formulation 4) and liraglutide at pH 7.7 (formulation 3).

Interventions

DRUGliraglutide

One single dose of 6.25 mg/mL administered subcutaneously

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

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 * 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

Design outcomes

Primary

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

Secondary

Measure	Time frame
t½, terminal half-life	—
Area under the curve	—
Adverse events	—
Terminal elimination rate constant	—
tmax, time to reach Cmax	—

Countries

Sweden

Outcome results

None listed

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