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Cilostazol-Simvastatin Drug Interaction Study

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: NCT02431013
Recruitment Status : Unknown
Verified April 2015 by Doo-Yeoun Cho, Ajou University School of Medicine.
Recruitment status was:  Recruiting
First Posted : April 30, 2015
Last Update Posted : May 1, 2015
Sponsor:
Information provided by (Responsible Party):
Doo-Yeoun Cho, Ajou University School of Medicine

Brief Summary:
This is a randomized, open-label, single & multiple-dose, parallel study to investigate the effect of cilostazol on the disposition of simvastatin & pravastatin in healthy male volunteers

Condition or disease Intervention/treatment Phase
Dyslipidemias Peripheral Artery Disease Drug: Simvastatin Drug: Pravastatin Drug: Cilostazol Phase 1

Detailed Description:

Eligibility for participation of this study will be determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks before study drug administration. Subjects suitable for this study will be admitted to the Clinical Trial Center of Ajou University Medical Center on the day before dosing (Day -1).

On Day 1, Subjects will be dosed simvastatin 40 mg or pravastatin 20 mg. Pharmacokinetic samplings and blood pressure/pulse rate measurement will be done upto 24 hours after dosing.

From Day 2 ~ 7, Subjects will be dosed cilostazol 100 mg twice a day. On Day 8, Subjects will be dosed simvastatin 40 mg or pravastatin 20 mg with cilostazol 100 mg twice a day. Pharmacokinetic samplings and blood pressure/pulse rate measurement will be done upto 24 hours after dosing.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Multiple-dose, Parallel Study to Investigate The Effect of Cilostazol on the Disposition of Simvastatin in Healthy Male Volunteers
Study Start Date : April 2015
Estimated Primary Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: Simvastatin+Cilostazol
Simvastatin 40 mg on Day 1. Cilostazol 100 mg twice a day for 6 days. Simvastatin 40 mg and Cilostazol 100 mg twice a day on Day 8.
Drug: Simvastatin
Simvastatin 40 mg on Day 1 & Day 8.
Other Name: S

Drug: Cilostazol
Cilostazol 100 mg twice a day for 6 days & on Day 8 with statin.
Other Name: C

Active Comparator: Pravastatin+Cilostazol
Pravastatin 20 mg on Day 1. Cilostazol 100 mg twice a day for 6 days. Pravastatin 20 mg and Cilostazol 100 mg twice a day on Day 8.
Drug: Pravastatin
Pravastatin 20 mg on Day 1 & Day 8.
Other Name: P

Drug: Cilostazol
Cilostazol 100 mg twice a day for 6 days & on Day 8 with statin.
Other Name: C




Primary Outcome Measures :
  1. AUC (area under the time-concentration curve) of Simvastatin [ Time Frame: up to 12 hours after Simvastatin dosing ]

Secondary Outcome Measures :
  1. Cmax (maximum plasma concentration) of Simvastatin [ Time Frame: up to 12 hours after Simvastatin dosing ]
  2. Cmax (maximum plasma concentration) of Pravastatin [ Time Frame: up to 12 hours after Pravastatin dosing ]
  3. AUC (area under the time-concentration curve) of Pravastatin [ Time Frame: up to 12 hours after Pravastatin dosing ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subjects aged 20 - 45 years
  • With in 20% of ideal body weight, {Ideal body weight=[height(cm)-100]*0.9}
  • Agreement with written informed consent

Exclusion Criteria:

  • Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal disease or mental disorder (Past history or present)
  • Inadequate result of laboratory test (especially, AST/ALT > 1.25 x UNL, Total bilirubin > 1.5 x UNL)
  • Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL test
  • Taking OTC(Over the counter)medicine including oriental medicine within 7 days
  • Clinically significant allergic disease (Except for mild allergic rhinitis and dermatitis seems to be not need for medication)
  • Subject with known for hypersensitivity reaction to Cilostazol, Simvastatin or Pravastatin
  • Previous whole blood donation within 60 days or component blood donation within 30 days
  • Previous participation of other trial within 90 days
  • Continued taking caffeine (caffeine > 5 cup/day), drinking (alcohol > 30 g/day) and severe heavy smoker (cigarette > 1/2 pack per day)
  • An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result

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): NCT02431013


Contacts
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Contact: Doo-Yeoun Cho, MD +82-31-219-4271 dooycho@ajou.ac.kr

Locations
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Korea, Republic of
Ajou University Medical Center Recruiting
Suwon, Gyeonggi, Korea, Republic of, 443-380
Contact: Doo-Yeoun Cho, MD    +82-31-219-4271    dooycho@ajou.ac.kr   
Principal Investigator: Doo-Yeoun Cho, MD         
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
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Principal Investigator: Doo-Yeoun Cho, MD Ajou University School of Medicine
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Responsible Party: Doo-Yeoun Cho, Assistant Professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT02431013    
Other Study ID Numbers: DDI-103
First Posted: April 30, 2015    Key Record Dates
Last Update Posted: May 1, 2015
Last Verified: April 2015
Keywords provided by Doo-Yeoun Cho, Ajou University School of Medicine:
Drug-drug interaction
Pharmacokinetics
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Cilostazol
Simvastatin
Pravastatin
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