Pharmacodynamic Drug Interaction Between Cilostazol and Statins

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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C -> C + S

cilostazol (C) in period 1, cilostazol + simvastatin (C+S) in period 2

Group Type EXPERIMENTAL

Cilostazol

Intervention Type DRUG

cilostazol bid for 7 days

Simvastatin

Intervention Type DRUG

simvastatin qd for 7 days

C + S -> C

cilostazol + simvastatin (C+S) in period 1, cilostazol (C) in period 2

Group Type EXPERIMENTAL

Cilostazol

Intervention Type DRUG

cilostazol bid for 7 days

Simvastatin

Intervention Type DRUG

simvastatin qd for 7 days

S -> S + C

simvastatin (S) in period 1, simvastatin + cilostazol (S+C) in period 2

Group Type EXPERIMENTAL

Cilostazol

Intervention Type DRUG

cilostazol bid for 7 days

Simvastatin

Intervention Type DRUG

simvastatin qd for 7 days

C + S -> S

cilostazol + simvastatin (C+S) in period 1, simvastatin (S) in period 2

Group Type EXPERIMENTAL

Cilostazol

Intervention Type DRUG

cilostazol bid for 7 days

Simvastatin

Intervention Type DRUG

simvastatin qd for 7 days

R -> C + R

rosuvastatin (R) in period 1, cilostazol + rosuvastatin (C+R) in period 2

Group Type EXPERIMENTAL

Cilostazol

Intervention Type DRUG

cilostazol bid for 7 days

Rosuvastatin

Intervention Type DRUG

rosuvastatin qd for 7 days

C + R -> R

cilostazol + rosuvastatin (C+R) in period 1, rosuvastatin (R) in period 2

Group Type EXPERIMENTAL

Cilostazol

Intervention Type DRUG

cilostazol bid for 7 days

Rosuvastatin

Intervention Type DRUG

rosuvastatin qd for 7 days

Interventions

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Cilostazol

cilostazol bid for 7 days

Intervention Type DRUG

Simvastatin

simvastatin qd for 7 days

Intervention Type DRUG

Rosuvastatin

rosuvastatin qd for 7 days

Intervention Type DRUG

Other Intervention Names

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cilostazol (C); Plettal 100 mg simvastatin (S); Zocor 40 mg Rosuvastatin (R); Crestor 20 mg

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes