Effect of Liraglutide on Gastrointestinal Absorption of Several Drugs and Potential Influence of Liraglutide on Intragastric pH
NCT ID: NCT01518166
Last Updated: 2017-01-25
Study Results
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Basic Information
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COMPLETED
PHASE1
70 participants
INTERVENTIONAL
2006-05-31
2007-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Trial period A
liraglutide
Administered as a subcutaneous injection. Initial dose 0.6 mg daily, adjusted to 1.2 mg daily in week 2 and escalated to 1.8 mg daily in week 3
placebo
Administered as a subcutaneous injection. Given as daily volume of 100 mcl, 200 mcl and 300 mcl respectively
atorvastatin
One single dose of 40 mg. Tablet
lisinopril
One single dose of 20 mg. Tablet
Trial period B
liraglutide
Administered as a subcutaneous injection. Initial dose 0.6 mg daily, adjusted to 1.2 mg daily in week 2 and escalated to 1.8 mg daily in week 3
placebo
Administered as a subcutaneous injection. Given as daily volume of 100 mcl, 200 mcl and 300 mcl respectively
griseofulvin
One single dose of 500 mg. Tablet
digoxin
One single dose of 1 mg. Tablet
Interventions
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liraglutide
Administered as a subcutaneous injection. Initial dose 0.6 mg daily, adjusted to 1.2 mg daily in week 2 and escalated to 1.8 mg daily in week 3
placebo
Administered as a subcutaneous injection. Given as daily volume of 100 mcl, 200 mcl and 300 mcl respectively
atorvastatin
One single dose of 40 mg. Tablet
lisinopril
One single dose of 20 mg. Tablet
griseofulvin
One single dose of 500 mg. Tablet
digoxin
One single dose of 1 mg. Tablet
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) of 18-30 kg/m\^2 (both inclusive)
* 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
* Willing and capable to self-administer a subcutaneous injection
Exclusion Criteria
* Impaired renal function
* Blood pressure and heart rate in supine position outside the ranges 90-140 mmHg systolic, 50-90 mmHg diastolic and heart rate 40-100 beats/min
* Any clinically significant abnormal ECG
* Active hepatitis B and/or active hepatitis C
* Positive HIV (human immunodeficiency virus) antibodies
* Known or suspected allergy to trial product(s) or related products
* Use of any prescription or non-prescription medication except for paracetamol, nasal spray or drops for nasal congestion, and vitamins within 2 weeks prior to first dosing and during the entire trial period
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Uppsala, , Sweden
Countries
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References
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Malm-Erjefalt M, Ekblom M, Vouis J, Zdravkovic M, Lennernas H. Effect on the Gastrointestinal Absorption of Drugs from Different Classes in the Biopharmaceutics Classification System, When Treating with Liraglutide. Mol Pharm. 2015 Nov 2;12(11):4166-73. doi: 10.1021/acs.molpharmaceut.5b00278. Epub 2015 Oct 12.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2006-000175-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN2211-1608
Identifier Type: -
Identifier Source: org_study_id
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