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

This study has been completed.

First Received: June 2, 2008 Last Updated: January 12, 2009 History of Changes

Sponsor:	SK Chemicals Co.,Ltd.
Information provided by:	SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier:	NCT00689858

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: Cilostazol, Ginkgo biloba and placebo	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
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.

Resource links provided by NLM:

Drug Information available for: Cilostazol

U.S. FDA Resources

Further study details as provided by SK Chemicals Co.,Ltd.:

Primary Outcome Measures:

Maximum plasma concetration of Cilostazol at steady state [ Time Frame: within 12hrs after cilostazol ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PD parameter: change from baseline after administration (change value of aggregation %) [ Time Frame: within 12hrs after cilostazol ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	May 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Period 1: Cilostazol, Ginkgo biloba Period 2:Cilostazol, placebo	Drug: Cilostazol, Ginkgo biloba and placebo dosing time
2: Active Comparator Period 1: Cilostazol, placebo Period 2: Cilostazol, Ginkgo biloba	Drug: Cilostazol, Ginkgo biloba and placebo dosing time

Eligibility

Ages Eligible for Study:	19 Years to 45 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689858

Locations

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

Sponsors and Collaborators

SK Chemicals Co.,Ltd.

Investigators

Principal Investigator:

Jae Gook Shin, MD,PhD

Inje University Pusan Paik Hospital

More Information

No publications provided

Responsible Party:	SK Chemicals Co.,Ltd. ( Clinical Research Team Organization: SK Chemicals Co.,Ltd. )
Study ID Numbers:	GETC_DDI_I_2008
Study First Received:	June 2, 2008
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00689858 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by SK Chemicals Co.,Ltd.:

Healthy volunteers

Additional relevant MeSH terms:

Cilostazol
Respiratory System Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Enzyme Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Protective Agents

Neuroprotective Agents
Pharmacologic Actions
Fibrin Modulating Agents
Phosphodiesterase Inhibitors
Autonomic Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents
Central Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on November 09, 2009