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Pharmacodynamic Drug Interaction Between Cilostazol and Statins

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: Cilostazol (Drug); Simvastatin (Drug); Rosuvastatin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Samsung Medical Center

Official(s) and/or principal investigator(s):
Jae-Wook Ko, MD, PhD, Principal Investigator, Affiliation: Samsung Medical Center

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: lipid lowering effect

Secondary outcome: anti-platelet effect

Detailed description: 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.

Eligibility

Minimum age: 20 Years. Maximum age: 55 Years. Gender(s): Male.

Criteria:

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

Locations and Contacts

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

Starting date: June 2012
Last updated: May 22, 2015

Page last updated: August 23, 2015

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