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

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ClinicalTrials.gov Identifier: NCT00689858
Recruitment Status : Completed
First Posted : June 4, 2008
Last Update Posted : January 13, 2009
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Cilostazol, Ginkgo biloba and placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Trial to Assessment the PK/PD Characteristics and Safety After co-Administration of Cilostazol With Ginkgo Biloba or Placebo in Healthy Subject.
Study Start Date : May 2007
Primary Completion Date : July 2008
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Maximum plasma concetration of Cilostazol at steady state [ Time Frame: within 12hrs after cilostazol ]

Secondary Outcome Measures :
  1. PD parameter: change from baseline after administration (change value of aggregation %) [ Time Frame: within 12hrs after cilostazol ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

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): NCT00689858


Locations
Korea, Republic of
INJE University Pusan Paik Hospital
Pusan, Korea, Republic of
SK chemicals
Seoul, Korea, Republic of, 110-744
SKChemicals
Seoul, Korea, Republic of
Sponsors and Collaborators
SK Chemicals Co.,Ltd.
Investigators
Principal Investigator: Jae Gook Shin, MD,PhD Inje University
More Information

Responsible Party: Clinical Research Team Organization: SK Chemicals Co.,Ltd., SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT00689858     History of Changes
Other Study ID Numbers: GETC_DDI_I_2008
First Posted: June 4, 2008    Key Record Dates
Last Update Posted: January 13, 2009
Last Verified: June 2008

Keywords provided by SK Chemicals Co.,Ltd.:
Healthy volunteers

Additional relevant MeSH terms:
Cilostazol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors