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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01508897 |
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Date of registration:
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09/01/2012 |
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Primary sponsor: |
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Public title:
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Comparison of Two Liraglutide Formulations in Healthy Volunteers
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Scientific title:
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A Randomized, Single-blind, Single-centre, Two-period, Cross-over Trial Investigating the Bioequivalence Between Completed Phase 2 and Planned Phase 3 Formulations of Liraglutide in Healthy Subjects |
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Date of first enrolment:
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May 2004 |
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Target sample size:
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22 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01508897 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Countries of recruitment
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Germany
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Contacts
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Name:
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Milan Zdravkovic, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novo Nordisk |
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Key inclusion & exclusion criteria
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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
- Body Mass Index (BMI) of 18-27 kg/m^2 incl.
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
- Impaired renal function
- Uncontrolled treated/untreated hypertension
- Any clinically significant abnormal ECG
- Active hepatitis B and/or active hepatitis C
- Positive HIV (human immunodeficiency virus) antibodies
- 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
- Excessive consumption of a diet deviating from a normal diet as judged by the
Investigator
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes
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Healthy
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Intervention(s)
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Drug: liraglutide
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Primary Outcome(s)
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Area under the Curve (AUC) (0-t)
[Time Frame: No]
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Cmax, maximum concentration
[Time Frame: No]
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Secondary Outcome(s)
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Adverse events
[Time Frame: No]
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AUC (0-infinity)
[Time Frame: No]
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t½, terminal half-life
[Time Frame: No]
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Terminal elimination rate constant
[Time Frame: No]
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tmax, time to maximum concentration
[Time Frame: No]
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Secondary ID(s)
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NN2211-1331
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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