Study to Assess the Effect of Pharmacokinetics/Pharmacodynamics (PK/PD) Interaction After co-Administration of Cilostazol With Ginkgo Biloba or Placebo

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-07-31

Brief Summary

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TO assess the PK/PD effect of co-administerd Cilostazol with Ginkgo biloba or placebo, Phase I study in healthy Volunteers were designed

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Period 1: Cilostazol, Ginkgo biloba Period 2:Cilostazol, placebo

Group Type EXPERIMENTAL

Cilostazol, Ginkgo biloba and placebo

Intervention Type DRUG

dosing time

2

Period 1: Cilostazol, placebo Period 2: Cilostazol, Ginkgo biloba

Group Type ACTIVE_COMPARATOR

Cilostazol, Ginkgo biloba and placebo

Intervention Type DRUG

dosing time

Interventions

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Cilostazol, Ginkgo biloba and placebo

dosing time

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy male adult volunteer between 19 and 45 years of age and within 15% of ideal body weight by broca's formula.
* the subjects who doesn't have any congenital or chronic diseases and symptoms or signs of diseases after physical examinations.\]

Exclusion Criteria

* the subject who has abnornal lab. ( In particular, AST or ALT \> 1.25 times of upper limit / Total bilirubin \> 1.5 times of upper limit/170,000 \< Platelet \< 360,000 / PT or aPTT or BT\> \>upper limit
* the subject who receive any metabolic enzyme inducing or inhibiting drugs like barbiturates or drink excess alcohol within 1 month prior to the study.

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes