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Completed

NCT Number: NCT01870466

Pharmacodynamic Drug Interaction Between Cilostazol and Statins

The purpose of this study is to evaluate pharmacodynamic drug interaction between cilostazol and statins (simvastatin as a CYP3A substrate and rosuvastatin as a non-CYP3A substrate) in healthy male subjects.

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Key information

Conditions

Healthy

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Samsung Medical Center

Seoul, South Korea

About this study

Subjects suitable for this study will visit to the Clinical Trial Center, Samsung Medical Center for 7 days and pharmacodynamic samplings will be performed following the administration of study drugs.

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 - 55 years
  • A body mass index in the range 18.5 - 27 kg/m2
  • Willingness to participate during the entire study period
  • Written informed consent after being fully informed about the study procedures

Exclusion criteria

  • Any past medical history of hepatic, renal, neurologic, cardiovascular, respiratory, endocrine, hemato-oncologic or psychiatric disease
  • Active bleeding or bleeding tendency
  • History of gastrointestinal disease or surgery possibly affecting drug absorption
  • History of clinically significant drug hypersensitivity
  • Use of medication within 7 days before the first dose
  • Heavy drinker (>140 g/week)
  • Whole blood donation during 60 days before the study
  • Judged not eligible for study participation by investigator

Treatment and study plan

Cilostazol

Drug

cilostazol bid for 7 days

Other names: cilostazol (C); Plettal 100 mg

simvastatin

Drug

simvastatin qd for 7 days

Other names: simvastatin (S); Zocor 40 mg

Rosuvastatin

Drug

rosuvastatin qd for 7 days

Other names: Rosuvastatin (R); Crestor 20 mg

Primary outcomes

  1. lipid lowering effect

    Time frame: 7 days

    lipid panel

Secondary outcomes

  1. anti-platelet effect

    Time frame: 7 days

    platelet aggregation test

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacodynamic Drug Interaction Between Cilostazol and Statins in Healthy Male Volunteer

Acronym: SMCCPT-100

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 6, 2013
Registry last updated
May 27, 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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