Comparison of Three Liraglutide Formulations in Healthy Volunteers

Healthy Clinical Trial

Official title:

A Randomised, Double-blind, Single-centre, Three-period, Cross-over Trial in Healthy Subjects Investigating the 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01514487
• Other study ID #: NN2211-1636
• Status: Completed
• Phase: Phase 1
• First received: January 17, 2012
• Last updated: February 28, 2017
• Start date: January 13, 2005
• Est. completion date: March 30, 2005

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 30, 2005
• Est. primary completion date: March 30, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• liraglutide
One single dose of 0.75 mg administered on three different dosing occasions with a 14-day wash-out period between each dosing. Injected subtaneously

Locations

Country	Name	City	State
Australia	Novo Nordisk Investigational Site	Adelaide

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the Curve (0-t)
Primary	Cmax, maximum concentration
Secondary	Area under the curve (0-infinity)
Secondary	tmax, time to reach Cmax
Secondary	t½, terminal half-life
Secondary	Terminal elimination rate constant
Secondary	Adverse events

External Links

•   Clinical Trials at Novo Nordisk