Comparison of Three Liraglutide Formulations in Healthy Volunteers

February 28, 2017 updated by: Novo Nordisk A/S

A Randomised, Double-blind, Single-centre, Three-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between Each of the Two New Liraglutide Formulations at pH 7.9 and 8.15 and the Planned Phase 3 Formulation at pH 7.7

This trial is conducted in Oceania. The aim of this trial is to test for bioequivalence between each of the two new liraglutide formulations at pH 7.9 and 8.15 and the planned Phase 3 formulation at pH 7.7.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia, 5000
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy subjects
  • 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, 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 study, as judged by the investigator
  • Family or personal history of Primary hyperparathyroidism or pheochromocytoma or thyroid malignancy or multiple endocrine neoplasia
  • Impaired renal function
  • Uncontrolled treated/untreated hypertension
  • Any clinically significant abnormal ECG
  • Active hepatitis B and/or active hepatitis C
  • Positive HIV (human immunideficiency virus) 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
  • Prescription or non-prescription medication, except for paracetamol and vitamins
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pH 7.7
Drug: liraglutide
One single dose of 0.75 mg administered on three different dosing occasions with a 14-day wash-out period between each dosing. Injected subtaneously
Experimental: pH 7.9
Drug: liraglutide
One single dose of 0.75 mg administered on three different dosing occasions with a 14-day wash-out period between each dosing. Injected subtaneously
Experimental: pH 8.15
Drug: liraglutide
One single dose of 0.75 mg administered on three different dosing occasions with a 14-day wash-out period between each dosing. Injected subtaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Cmax, maximum concentration
Area under the Curve (0-t)

Secondary Outcome Measures

Outcome Measure
Adverse events
tmax, time to reach Cmax
t½, terminal half-life
Terminal elimination rate constant
Area under the curve (0-infinity)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2005

Primary Completion (Actual)

March 30, 2005

Study Completion (Actual)

March 30, 2005

Study Registration Dates

First Submitted

January 17, 2012

First Submitted That Met QC Criteria

January 20, 2012

First Posted (Estimate)

January 23, 2012

Study Record Updates

Last Update Posted (Actual)

March 1, 2017

Last Update Submitted That Met QC Criteria

February 28, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN2211-1636

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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