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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

Information source: SK Chemicals Co.,Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Cilostazol, Ginkgo biloba and placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: SK Chemicals Co.,Ltd.

Official(s) and/or principal investigator(s):
Jae Gook Shin, MD,PhD, Principal Investigator, Affiliation: Inje University


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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Maximum plasma concetration of Cilostazol at steady state

Secondary outcome: PD parameter: change from baseline after administration (change value of aggregation %)


Minimum age: 19 Years. Maximum age: 45 Years. Gender(s): Male.


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.

Locations and Contacts

INJE University Pusan Paik Hospital, Pusan, Korea, Republic of

SK chemicals, Seoul 110-744, Korea, Republic of

SKChemicals, Seoul, Korea, Republic of

Additional Information

Starting date: May 2007
Last updated: January 12, 2009

Page last updated: August 23, 2015

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