Pharmacodynamic Drug Interaction Between Cilostazol and Statins

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Cilostazol; Drug: Simvastatin; Drug: Rosuvastatin

• Registration Number: NCT01870466
• Lead Sponsor: Samsung Medical Center

Brief 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.

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.

Study Timeline

• Study First Submitted: 2012-05-04
• Study Start: 2012-06
• Study First Submitted QC: 2013-06-03
• Study First Posted: 2013-06-06
• Primary Completion: 2013-09
• Study Completion: 2013-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-22
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 63

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
S -> S + C	Simvastatin	simvastatin (S) in period 1, simvastatin + cilostazol (S+C) in period 2
C -> C + S	Simvastatin	cilostazol (C) in period 1, cilostazol + simvastatin (C+S) in period 2
S -> S + C	Cilostazol	simvastatin (S) in period 1, simvastatin + cilostazol (S+C) in period 2
C + S -> C	Cilostazol	cilostazol + simvastatin (C+S) in period 1, cilostazol (C) in period 2
C -> C + S	Cilostazol	cilostazol (C) in period 1, cilostazol + simvastatin (C+S) in period 2
C + S -> C	Simvastatin	cilostazol + simvastatin (C+S) in period 1, cilostazol (C) in period 2
R -> C + R	Rosuvastatin	rosuvastatin (R) in period 1, cilostazol + rosuvastatin (C+R) in period 2
C + S -> S	Cilostazol	cilostazol + simvastatin (C+S) in period 1, simvastatin (S) in period 2
C + S -> S	Simvastatin	cilostazol + simvastatin (C+S) in period 1, simvastatin (S) in period 2
C + R -> R	Rosuvastatin	cilostazol + rosuvastatin (C+R) in period 1, rosuvastatin (R) in period 2
R -> C + R	Cilostazol	rosuvastatin (R) in period 1, cilostazol + rosuvastatin (C+R) in period 2
C + R -> R	Cilostazol	cilostazol + rosuvastatin (C+R) in period 1, rosuvastatin (R) in period 2

Primary Outcome Measures

Name	Time	Method
lipid lowering effect	7 days	lipid panel

Secondary Outcome Measures

Name	Time	Method
anti-platelet effect	7 days	platelet aggregation test

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of