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)
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1
INJE University Pusan Paik Hospital
Pusan, South Korea
2
SK chemicals
Seoul, South Korea, 110-744
3
SKChemicals
Seoul, South Korea