Status:

COMPLETED

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

Lead Sponsor:

SK Chemicals Co., Ltd.

Conditions:

Healthy

Eligibility:

MALE

19-45 years

Phase:

PHASE1

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

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

May 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2008

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT00689858

Start Date

May 1 2007

End Date

July 1 2008

Last Update

January 13 2009

Active Locations (3)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (3 locations)

1

INJE University Pusan Paik Hospital

Pusan, South Korea

2

SK chemicals

Seoul, South Korea, 110-744

3

SKChemicals

Seoul, South Korea