Effect of Cilostazol on the Pharmacokinetics of Simvastatin

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

To evaluate the effect of cilostazol on the pharmacokinetics of simvastatin in healthy adult subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Samsung Medical Center
• Collaborator: Inje University
• Treatments: Cilostazol; Simvastatin

Criteria

Inclusion Criteria:

• Healthy male subjects aged 20 - 48 years

• A body mass index (BMI) in the range 19-27 kg/m2

• Provide written informed consent after being fully informed about the study procedures

• Subject without any congenital or chronic disease and with no pathologic symptom in the physical examination

• Determined eligible in the ECG, clinical laboratory tests and urinalysis

Exclusion Criteria:

• Use of medication which induces or inhibits drug metabolizing enzyme (CYP3A4 etc.) within 30 days prior to drug dosing

• Use of medication within 10 days before first dose

• Abnormal diet that can influence on tlhe ADME of drugs (grapefruit juice etc.)

• Presence or history of clinically significant allergic disease, alcohol abuse, drug hypersensitivity

• Whole blood donation during 60 days before the study

• Participation in other clinical trial within 90 days prior to scheduled study drug administration

• Subject judged not eligible for study participation by investigator