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Effect of Cilostazol on the Pharmacokinetics of Simvastatin

Information source: Samsung Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: simvastatin/cilostazol (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Samsung Medical Center

Official(s) and/or principal investigator(s):
JaeWook Ko, MD, Principal Investigator, Affiliation: Samsung Medical Center


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

Clinical Details

Official title: Effect of Cilostazol on the Pharmacokinetics of Simvastatin in Healthy Adult Subjects

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Plasma concentration of simvastatin

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


Minimum age: 20 Years. Maximum age: 48 Years. Gender(s): Male.


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


- 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


- Whole blood donation during 60 days before the study

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


- Subject judged not eligible for study participation by investigator

Locations and Contacts

Samsung Medical Center Clinical Trial Center, Seoul, Korea, Republic of
Additional Information

Starting date: June 2011
Last updated: May 18, 2015

Page last updated: August 23, 2015

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