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Pharmacodynamic Drug Interaction Between Cilostazol and Statins (SMCCPT-100)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01870466
Recruitment Status : Completed
First Posted : June 6, 2013
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Cilostazol Drug: Simvastatin Drug: Rosuvastatin 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.

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Study Type : Interventional  (Clinical Trial)
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 : June 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


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 Name: cilostazol (C); Plettal 100 mg

Drug: Simvastatin
simvastatin qd for 7 days
Other Name: 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 Name: cilostazol (C); Plettal 100 mg

Drug: Simvastatin
simvastatin qd for 7 days
Other Name: 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 Name: cilostazol (C); Plettal 100 mg

Drug: Simvastatin
simvastatin qd for 7 days
Other Name: 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 Name: cilostazol (C); Plettal 100 mg

Drug: Simvastatin
simvastatin qd for 7 days
Other Name: 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 Name: cilostazol (C); Plettal 100 mg

Drug: Rosuvastatin
rosuvastatin qd for 7 days
Other Name: 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 Name: cilostazol (C); Plettal 100 mg

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




Primary Outcome Measures :
  1. lipid lowering effect [ Time Frame: 7 days ]
    lipid panel


Secondary Outcome Measures :
  1. anti-platelet effect [ Time Frame: 7 days ]
    platelet aggregation test



Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01870466


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Jae-Wook Ko, MD, PhD Samsung Medical Center
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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01870466    
Other Study ID Numbers: 2011-11-004
First Posted: June 6, 2013    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Cilostazol
Rosuvastatin Calcium
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors