Bioequivalence of Two Liraglutide Formulations in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01515553
First received: January 18, 2012
Last updated: January 23, 2012
Last verified: January 2012
  Purpose

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).


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 3a Formulation of Liraglutide (Formulation 4) and the Planned Phase 3b Formulation (Final Formulation 4)

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

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 (0-infinity) [ Designated as safety issue: No ]
  • Relative bioavailability [ Designated as safety issue: No ]
  • Time to reach maximum (tmax) [ Designated as safety issue: No ]
  • Terminal elimination half life (t½) [ 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: January 2007
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Formulation 4 Drug: liraglutide
Two single doses of 0.72 mg liraglutide administered subcutaneously on two different dosing occasions separated by a wash-out period
Experimental: Final formulation 4 Drug: liraglutide
Two single doses of 0.72 mg liraglutide administered subcutaneously on two different dosing occasions separated by a wash-out period

  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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01515553

Locations
Sweden
Lund, Sweden, 221 85
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Milan Zdravkovic, MD, PhD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01515553     History of Changes
Other Study ID Numbers: NN2211-1692, 2006-004283-31
Study First Received: January 18, 2012
Last Updated: January 23, 2012
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 28, 2014