Effect of Cilostazol on the Pharmacokinetics of Simvastatin

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: simvastatin/cilostazol

• Registration Number: NCT01383395
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

Detailed Description

Eligibility for participation of this study was determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks before study drug administration. Subjects suitable for this study were admitted to the Clinical Trials Center, Samsung Medical Center on the day before dosing, and they were overnight-fasted from 10 p.m. of Day -1. Subjects were dosed simvastatin 40 mg orally around at 9 a.m. of Day 1. Subjects performed scheduled procedures including clinical laboratory tests and pharmacokinetic samplings for simvastatin. Subjects were dosed cilostazol 100 mg in the morning on Day 2 and discharged, and visited Clinical Trials Center on Day 3, Day 4 and Day 5 for the oral administration of cilostazol 100 mg. Subjects was admitted in the evening on day 5 and dosed simvastatin 40 mg plus cilostazol 100 mg concomitantly and scheduled pharmacokinetic sampling for simvastatin was performed. Next morning (Day 7), subjects were discharged

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-27
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-28
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-05
• Last Update Submitted: 2015-05-18
• Last Update Posted: 2015-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
simvastatin/cilostazol	simvastatin/cilostazol	simvastatin 40 mg on day 1 and 6, cilostazol 100 mg from day 2 to day 6

Primary Outcome Measures

Name	Time	Method
Plasma concentration of simvastatin	7 days	Plasma concentration of simvastin on day 1 and day 6

Trial Locations

Locations (1)

Samsung Medical Center Clinical Trial Center; 🇰🇷 Seoul, Korea, Republic of