Clinical Trial to Investigate the Pharmacokinetics/Pharmacodynamics of Sitagliptin
- Registration Number
- NCT00960453
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
The purpose of this study is to investigate the pharmacokinetics and pharmacodynamics of sitagliptin in healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sitagliptin 25mg Sitagliptin Repeated administrations for 4 days Sitagliptin 50mg Sitagliptin Repeated administrations for 4 days Sitagliptin 100mg Sitagliptin Repeated administrations for 4 days
- Primary Outcome Measures
Name Time Method 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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Trials Center; Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of