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Completed

NCT Number: NCT01383395

Effect of Cilostazol on the Pharmacokinetics of Simvastatin

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

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Key information

Conditions

Healthy

Age range

20 year–48 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Samsung Medical Center Clinical Trial Center

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

simvastatin/cilostazol

Drug

Primary outcomes

  1. Plasma concentration of simvastatin

    Time frame: 7 days

    Plasma concentration of simvastin on day 1 and day 6

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Inje University

Registry information

Official study title

Effect of Cilostazol on the Pharmacokinetics of Simvastatin in Healthy Adult Subjects

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 28, 2011
Registry last updated
May 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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