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

Tracking Information

First Received Date ^ICMJE

June 2, 2008

Last Updated Date

January 12, 2009

Start Date ^ICMJE

May 2007

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00689858 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: Cilostazol, Ginkgo biloba and placebo

Study Arms / Comparison Groups

Experimental: Period 1: Cilostazol, Ginkgo biloba Period 2:Cilostazol, placebo
Active Comparator: Period 1: Cilostazol, placebo Period 2: Cilostazol, Ginkgo biloba

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

19 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT ID ^ICMJE

NCT00689858

Responsible Party

Clinical Research Team Organization: SK Chemicals Co.,Ltd., SK Chemicals Co.,Ltd.

Study ID Numbers ^ICMJE

GETC_DDI_I_2008

Study Sponsor ^ICMJE

SK Chemicals Co.,Ltd.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Jae Gook Shin, MD,PhD

Inje University Pusan Paik Hospital

Information Provided By

SK Chemicals Co.,Ltd.

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP