Comparison of Two Liraglutide Formulations in Healthy Subjects

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 2 Formulation of Liraglutide at pH 7.7 (Formulation 3) and the Phase 3 Formulation at pH 8.15 (Formulation 4)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01515579
• Other study ID #: NN2211-1693
• Secondary ID: 2005-005948-68
• Status: Completed
• Phase: Phase 1
• First received: January 18, 2012
• Last updated: January 29, 2015
• Start date: April 2006
• Est. completion date: June 2006

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 at pH 8.15 (formulation 4) and liraglutide at pH 7.7 (formulation 3).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• 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

• Use of any prescription or non-prescription medication, except for paracetamol and vitamins, 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
One single dose of 6.25 mg/mL administered subcutaneously
• liraglutide
One single dose of 6.0 mg/mL administered subcutaneously

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			No
Secondary	tmax, time to reach Cmax			No
Secondary	t½, terminal half-life			No
Secondary	Terminal elimination rate constant			No
Secondary	Adverse events			No

External Links

•   Clinical Trials at Novo Nordisk