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
Summary
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
Eligibility
Minimum age: 20 Years.
Maximum age: 48 Years.
Gender(s): Male.
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
Locations and Contacts
Samsung Medical Center Clinical Trial Center, Seoul, Korea, Republic of
Additional Information
Starting date: June 2011
Last updated: May 18, 2015
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