Bioequivalence of Two Liraglutide Formulations in Healthy Volunteers

Healthy Clinical Trial

Official title:

A Randomized, Double-blind, Single-centre, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between the Phase 3a Formulation of Liraglutide (Formulation 4) and the Planned Phase 3b Formulation (Final Formulation 4)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01515553
• Other study ID #: NN2211-1692
• Secondary ID: 2006-004283-31
• Status: Completed
• Phase: Phase 1
• First received: January 18, 2012
• Last updated: January 12, 2015
• Start date: January 2007
• Est. completion date: April 2007

Study information

• Verified date: January 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• liraglutide
Two single doses of 0.72 mg liraglutide administered subcutaneously on two different dosing occasions separated by a wash-out period

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (0-t)			No
Primary	Cmax, maximum concentration			No
Secondary	Area under the curve (0-infinity)			No
Secondary	Relative bioavailability			No
Secondary	Time to reach maximum (tmax)			No
Secondary	Terminal elimination half life (t½)			No
Secondary	Terminal elimination rate constant			No
Secondary	Adverse events			No

External Links

•   Clinical Trials at Novo Nordisk