- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01515553
Bioequivalence of Two Liraglutide Formulations in Healthy Volunteers
January 12, 2015 updated by: Novo Nordisk A/S
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)
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).
Study Overview
Study Type
Interventional
Enrollment (Actual)
22
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
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Lund, Sweden, 221 85
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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:
- 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
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
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Formulation 4
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Two single doses of 0.72 mg liraglutide administered subcutaneously on two different dosing occasions separated by a wash-out period
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EXPERIMENTAL: Final formulation 4
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Two single doses of 0.72 mg liraglutide administered subcutaneously on two different dosing occasions separated by a wash-out period
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Area under the curve (0-t)
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Cmax, maximum concentration
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Secondary Outcome Measures
Outcome Measure |
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Adverse events
|
Terminal elimination rate constant
|
Time to reach maximum (tmax)
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Area under the curve (0-infinity)
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Relative bioavailability
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Terminal elimination half life (t½)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
January 1, 2007
Primary Completion (ACTUAL)
April 1, 2007
Study Completion (ACTUAL)
April 1, 2007
Study Registration Dates
First Submitted
January 18, 2012
First Submitted That Met QC Criteria
January 23, 2012
First Posted (ESTIMATE)
January 24, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
January 13, 2015
Last Update Submitted That Met QC Criteria
January 12, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN2211-1692
- 2006-004283-31 (EUDRACT_NUMBER)
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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