NCT02431013

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 30, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Last Updated

May 1, 2015

Status Verified

April 1, 2015

Enrollment Period

4 months

First QC Date

April 23, 2015

Last Update Submit

April 29, 2015

Conditions

DyslipidemiasPeripheral Artery Disease

Keywords

Drug-drug interactionPharmacokinetics

Outcome Measures

Primary Outcomes (1)

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

    up to 12 hours after Simvastatin dosing

Secondary Outcomes (3)

  • Cmax (maximum plasma concentration) of Simvastatin

    up to 12 hours after Simvastatin dosing

  • Cmax (maximum plasma concentration) of Pravastatin

    up to 12 hours after Pravastatin dosing

  • AUC (area under the time-concentration curve) of Pravastatin

    up to 12 hours after Pravastatin dosing

Study Arms (2)

Simvastatin+Cilostazol

EXPERIMENTAL

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: SimvastatinDrug: Cilostazol

Pravastatin+Cilostazol

ACTIVE COMPARATOR

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: PravastatinDrug: Cilostazol

Interventions

SimvastatinDRUG

Simvastatin 40 mg on Day 1 \& Day 8.

Also known as: S
Simvastatin+Cilostazol
PravastatinDRUG

Pravastatin 20 mg on Day 1 \& Day 8.

Also known as: P
Pravastatin+Cilostazol
CilostazolDRUG

Cilostazol 100 mg twice a day for 6 days \& on Day 8 with statin.

Also known as: C
Pravastatin+CilostazolSimvastatin+Cilostazol

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University Medical Center

Suwon, Gyeonggi-do, 443-380, South Korea

RECRUITING

MeSH Terms

Conditions

DyslipidemiasPeripheral Arterial Disease

Interventions

SimvastatinPravastatinCilostazol

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsTetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Doo-Yeoun Cho, MD

    Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Doo-Yeoun Cho, MD

CONTACT

+82-31-219-4271dooycho@ajou.ac.kr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 23, 2015

First Posted

April 30, 2015

Study Start

April 1, 2015

Primary Completion

August 1, 2015

Last Updated

May 1, 2015

Record last verified: 2015-04

Locations

KR(1)