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

January 12, 2009 updated by: SK Chemicals Co., Ltd.

Clinical Trial to Assessment the PK/PD Characteristics and Safety After co-Administration of Cilostazol With Ginkgo Biloba or Placebo in Healthy Subject.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Pusan, Korea, Republic of
        • Inje University Pusan Paik Hospital
      • Seoul, Korea, Republic of
        • SKChemicals
      • Seoul, Korea, Republic of, 110-744
        • SK chemicals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Period 1: Cilostazol, Ginkgo biloba Period 2:Cilostazol, placebo
Drug: Cilostazol, Ginkgo biloba and placebo
dosing time
ACTIVE_COMPARATOR: 2
Period 1: Cilostazol, placebo Period 2: Cilostazol, Ginkgo biloba
Drug: Cilostazol, Ginkgo biloba and placebo
dosing time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum plasma concetration of Cilostazol at steady state
Time Frame: within 12hrs after cilostazol
within 12hrs after cilostazol

Secondary Outcome Measures

Outcome Measure
Time Frame
PD parameter: change from baseline after administration (change value of aggregation %)
Time Frame: within 12hrs after cilostazol
within 12hrs after cilostazol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SK Chemicals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (ACTUAL)

July 1, 2008

Study Completion (ACTUAL)

July 1, 2008

Study Registration Dates

First Submitted

June 2, 2008

First Submitted That Met QC Criteria

June 3, 2008

First Posted (ESTIMATE)

June 4, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 13, 2009

Last Update Submitted That Met QC Criteria

January 12, 2009

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GETC_DDI_I_2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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