Diabetes Mellitus
Conditions
Brief summary
The purpose of this study is to investigate the pharmacokinetics and pharmacodynamics of sitagliptin in healthy volunteers.
Interventions
DRUGSitagliptin
Dosage form: 25mg, 50mg ,100mg Amount: 25mg, 50mg, 100mg Frequency and duration: once a day, for 4 days, including 5 days washout periods
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects aged 20 - 50 years * 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
* Presence or history of severe adverse reaction to any drug (e.g., sitagliptin) or a history of severe allergic disease * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the pharmacokinetics after repeated administrations of sitagliptin 25, 50 and 100 mg | Pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours after drug administration |
| To evaluate the pharmacodynamics (activity of Dipeptidyl peptidase-IV enzyme) after repeated administrations of sitagliptin 25, 50 and 100 mg | Pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours after drug administration |
Countries
South Korea
Outcome results
None listed