Clinical Trial to Investigate the Pharmacokinetics/Pharmacodynamics of Sitagliptin

Seoul National University

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus

Treatments

Drug: Sitagliptin

Study type

Interventional

Funder types

Other

Identifiers

SNUCPT09_Sitagliptin

Details and patient eligibility

About

The purpose of this study is to investigate the pharmacokinetics and pharmacodynamics of sitagliptin in healthy volunteers.

Enrollment

12 estimated patients

Sex

Male

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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