Status:
COMPLETED
Comparison of Two Liraglutide Formulations in Healthy Subjects
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01515579
Start Date
April 1 2006
End Date
June 1 2006
Last Update
January 30 2015
Active Locations (1)
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1
Lund, Sweden, 221 85