Clinical Trial to Investigate the Pharmacokinetics/Pharmacodynamics of Sitagliptin
NCT ID: NCT00960453
Last Updated: 2011-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2008-12-31
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
NONE
Study Groups
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Sitagliptin 25mg
Repeated administrations for 4 days
Sitagliptin
Dosage form: 25mg, 50mg ,100mg
Amount: 25mg, 50mg, 100mg
Frequency and duration: once a day, for 4 days, including 5 days washout periods
Sitagliptin 50mg
Repeated administrations for 4 days
Sitagliptin
Dosage form: 25mg, 50mg ,100mg
Amount: 25mg, 50mg, 100mg
Frequency and duration: once a day, for 4 days, including 5 days washout periods
Sitagliptin 100mg
Repeated administrations for 4 days
Sitagliptin
Dosage form: 25mg, 50mg ,100mg
Amount: 25mg, 50mg, 100mg
Frequency and duration: once a day, for 4 days, including 5 days washout periods
Interventions
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Sitagliptin
Dosage form: 25mg, 50mg ,100mg
Amount: 25mg, 50mg, 100mg
Frequency and duration: once a day, for 4 days, including 5 days washout periods
Eligibility Criteria
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Inclusion Criteria
* A body mass index (BMI) in the range 17-28 kg/m2
* Fasting plasma glucose levels in the range 70-110 mg/dL
* Sufficient ability to understand the nature of the study and any hazards of participating in it
* Provide written informed consent after being fully informed about the study procedures
Exclusion Criteria
* Clinically relevant abnormal medical history that could interfere with the objectives of the study
* A subject who has the following screening laboratory test results; creatinine clearance (calculated by Cockcroft-Gault equation) \< 80 mL/min
* History of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug
* A subject whose SBP is over 150 mmHg or below 100 mmHg and DBP is over 95 mmHg or below 65 mmHg
* Presence or history of drug abuse
* Participation in other clinical trial within 2 months
* Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication within 1 week before first dose
* Blood donation during 2 months or apheresis during 1 month before the study
* Presence or history of alcohol abuse
* Users of nicotine-containing substances within the previous three months
* Use of grapefruit juice, alcohol or smoking during restriction period
* Subject judged not eligible for study participation by investigator
20 Years
50 Years
MALE
Yes
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Seoul National University Hospital
Principal Investigators
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Kyung-Sang Yu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University College of Medicine and Hospital
Locations
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Clinical Trials Center; Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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SNUCPT09_Sitagliptin
Identifier Type: -
Identifier Source: org_study_id
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