Status:
COMPLETED
Comparison of Three Liraglutide Formulations in Healthy Volunteers
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 13 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2005
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01514487
Start Date
January 13 2005
End Date
March 30 2005
Last Update
March 1 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Adelaide, Australia, 5000