Comparison of Two Liraglutide Formulations in Healthy Subjects - Full Text View

Purpose

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).

Condition	Intervention	Phase
Diabetes Healthy	Drug: liraglutide	Phase 1

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

Resource links provided by NLM:

Drug Information available for: Liraglutide

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Area under the curve (0-t) [ Designated as safety issue: No ]
Cmax, maximum concentration [ Designated as safety issue: No ]

Secondary Outcome Measures:

Area under the curve [ Designated as safety issue: No ]
tmax, time to reach Cmax [ Designated as safety issue: No ]
t½, terminal half-life [ Designated as safety issue: No ]
Terminal elimination rate constant [ Designated as safety issue: No ]
Adverse events [ Designated as safety issue: No ]

Enrollment:	22
Study Start Date:	April 2006
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Formulation 3	Drug: liraglutide One single dose of 6.25 mg/mL administered subcutaneously
Experimental: Formulation 4	Drug: liraglutide One single dose of 6.0 mg/mL administered subcutaneously

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01515579

Locations

Sweden

Lund, Sweden, 221 85

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Milan Zdravkovic, MD, PhD

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT01515579 History of Changes
Other Study ID Numbers:	NN2211-1693, 2005-005948-68
Study First Received:	January 18, 2012
Last Updated:	January 18, 2012
Health Authority:	Sweden: Medical Products Agency

Additional relevant MeSH terms:

Glucagon-Like Peptide 1
Incretins
Hormones

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013