Effect of Cilostazol on the Pharmacokinetics of Simvastatin in Healthy Adult Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Samsung Medical Center
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Plasma concentration of simvastatin
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 48 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
simvastatin/cilostazol
simvastatin 40 mg on day 1 and 6, cilostazol 100 mg from day 2 to day 6
Intervention: simvastatin/cilostazol (Drug)
Outcomes
Primary Outcomes
Plasma concentration of simvastatin
Time Frame: 7 days
Plasma concentration of simvastin on day 1 and day 6
Secondary Outcomes
No secondary outcomes reported