Comparison of Two Liraglutide Formulations in Healthy Volunteers

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01508897
• Other study ID #: NN2211-1331
• Status: Completed
• Phase: Phase 1
• Start date: May 28, 2004
• Est. completion date: June 30, 2004

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 30, 2004
• Est. primary completion date: June 30, 2004
• Accepts healthy volunteers: No
• Gender: All
• 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

• 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

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• liraglutide
Single dose administered as subcutaneous injection
• liraglutide
Single dose administered as subcutaneous injection

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Neu-Ulm

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the Curve (AUC) (0-t)
Primary	Cmax, maximum concentration
Secondary	AUC (0-infinity)
Secondary	tmax, time to maximum concentration
Secondary	t½, terminal half-life
Secondary	Terminal elimination rate constant
Secondary	Adverse events

External Links

•   Clinical Trials at Novo Nordisk