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SMCCPT-100: Pharmacodynamic Drug Interaction Between Cilostazol and Statins

Sponsor
Samsung Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01870466
Collaborator
(none)
63
Enrollment
1
Location
6
Arms
18
Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
63 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
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 Start Date :
Jun 1, 2012
Actual Primary Completion Date :
Sep 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: C -> C + S

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

Drug: Cilostazol
cilostazol bid for 7 days
Other Names:
  • cilostazol (C); Plettal 100 mg

    • Drug: Simvastatin
    simvastatin qd for 7 days
    Other Names:
  • simvastatin (S); Zocor 40 mg

    		•
    Experimental: C + S -> C

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

    Drug: Cilostazol
    cilostazol bid for 7 days
    Other Names:
  • cilostazol (C); Plettal 100 mg

    • Drug: Simvastatin
    simvastatin qd for 7 days
    Other Names:
  • simvastatin (S); Zocor 40 mg

    		•
    Experimental: S -> S + C

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

    Drug: Cilostazol
    cilostazol bid for 7 days
    Other Names:
  • cilostazol (C); Plettal 100 mg

    • Drug: Simvastatin
    simvastatin qd for 7 days
    Other Names:
  • simvastatin (S); Zocor 40 mg

    		•
    Experimental: C + S -> S

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

    Drug: Cilostazol
    cilostazol bid for 7 days
    Other Names:
  • cilostazol (C); Plettal 100 mg

    • Drug: Simvastatin
    simvastatin qd for 7 days
    Other Names:
  • simvastatin (S); Zocor 40 mg

    		•
    Experimental: R -> C + R

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

    Drug: Cilostazol
    cilostazol bid for 7 days
    Other Names:
  • cilostazol (C); Plettal 100 mg

    • Drug: Rosuvastatin
    rosuvastatin qd for 7 days
    Other Names:
  • Rosuvastatin (R); Crestor 20 mg

    		•
    Experimental: C + R -> R

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

    Drug: Cilostazol
    cilostazol bid for 7 days
    Other Names:
  • cilostazol (C); Plettal 100 mg

    • Drug: Rosuvastatin
    rosuvastatin qd for 7 days
    Other Names:
  • Rosuvastatin (R); Crestor 20 mg

    		•

    Outcome Measures

    Primary Outcome Measures

    1. lipid lowering effect [7 days]

      lipid panel

    Secondary Outcome Measures

    1. anti-platelet effect [7 days]

      platelet aggregation test

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 55 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samsung Medical Center Seoul Korea, Republic of

    Sponsors and Collaborators

    • Samsung Medical Center

    Investigators

    • Principal Investigator: Jae-Wook Ko, MD, PhD, Samsung Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Samsung Medical Center
    ClinicalTrials.gov Identifier:
    NCT01870466
    Other Study ID Numbers:
    • 2011-11-004
    First Posted:
    Jun 6, 2013
    Last Update Posted:
    May 27, 2015
    Last Verified:
    May 1, 2015
    Additional relevant MeSH terms:
    Cilostazol
    Rosuvastatin Calcium
    Simvastatin

    Study Results

    No Results Posted as of May 27, 2015