Comparison of Two Liraglutide Formulations in Healthy Subjects
- Registration Number
- NCT01515579
- Lead Sponsor
- Novo Nordisk A/S
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
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
- Use of any prescription or non-prescription medication, except for paracetamol and vitamins, as judged by the Investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Formulation 3 liraglutide - Formulation 4 liraglutide -
- Primary Outcome Measures
Name Time Method Area under the curve (0-t) Cmax, maximum concentration
- Secondary Outcome Measures
Name Time Method Area under the curve tmax, time to reach Cmax t½, terminal half-life Terminal elimination rate constant Adverse events