Status:
COMPLETED
Clinical Trial to Investigate the Pharmacokinetics/Pharmacodynamics of Sitagliptin
Lead Sponsor:
Seoul National University Hospital
Conditions:
Diabetes Mellitus
Eligibility:
MALE
20-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate the pharmacokinetics and pharmacodynamics of sitagliptin in healthy volunteers.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00960453
Start Date
December 1 2008
Last Update
February 23 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Trials Center; Seoul National University Hospital
Seoul, South Korea, 110-744