Comparison of Three Liraglutide Formulations in Healthy Volunteers
- Registration Number
- NCT01514487
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description pH 7.7 liraglutide - pH 7.9 liraglutide - pH 8.15 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 (0-infinity) tmax, time to reach Cmax t½, terminal half-life Terminal elimination rate constant Adverse events
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇦🇺Adelaide, Australia