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Cilostazol-Simvastatin Drug Interaction Study

Primary Purpose

Dyslipidemias, Peripheral Artery Disease

Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Simvastatin
Pravastatin
Cilostazol
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemias focused on measuring Drug-drug interaction, Pharmacokinetics

Eligibility Criteria

20 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Ajou University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Simvastatin+Cilostazol

Pravastatin+Cilostazol

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

AUC (area under the time-concentration curve) of Simvastatin

Secondary Outcome Measures

Cmax (maximum plasma concentration) of Simvastatin
Cmax (maximum plasma concentration) of Pravastatin
AUC (area under the time-concentration curve) of Pravastatin

Full Information

First Posted
April 23, 2015
Last Updated
April 29, 2015
Sponsor
Ajou University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02431013
Brief Title
Cilostazol-Simvastatin Drug Interaction Study
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 Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias, Peripheral Artery Disease
Keywords
Drug-drug interaction, Pharmacokinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Simvastatin+Cilostazol
Arm Type
Experimental
Arm Description
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.
Arm Title
Pravastatin+Cilostazol
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Other Intervention Name(s)
S
Intervention Description
Simvastatin 40 mg on Day 1 & Day 8.
Intervention Type
Drug
Intervention Name(s)
Pravastatin
Other Intervention Name(s)
P
Intervention Description
Pravastatin 20 mg on Day 1 & Day 8.
Intervention Type
Drug
Intervention Name(s)
Cilostazol
Other Intervention Name(s)
C
Intervention Description
Cilostazol 100 mg twice a day for 6 days & on Day 8 with statin.
Primary Outcome Measure Information:
Title
AUC (area under the time-concentration curve) of Simvastatin
Time Frame
up to 12 hours after Simvastatin dosing
Secondary Outcome Measure Information:
Title
Cmax (maximum plasma concentration) of Simvastatin
Time Frame
up to 12 hours after Simvastatin dosing
Title
Cmax (maximum plasma concentration) of Pravastatin
Time Frame
up to 12 hours after Pravastatin dosing
Title
AUC (area under the time-concentration curve) of Pravastatin
Time Frame
up to 12 hours after Pravastatin dosing

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Doo-Yeoun Cho, MD
Phone
+82-31-219-4271
Email
dooycho@ajou.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doo-Yeoun Cho, MD
Organizational Affiliation
Ajou University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ajou University Medical Center
City
Suwon
State/Province
Gyeonggi
ZIP/Postal Code
443-380
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doo-Yeoun Cho, MD
Phone
+82-31-219-4271
Email
dooycho@ajou.ac.kr
First Name & Middle Initial & Last Name & Degree
Doo-Yeoun Cho, MD

12. IPD Sharing Statement

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Cilostazol-Simvastatin Drug Interaction Study

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