Study to Assess the Effect of Pharmacokinetics/Pharmacodynamics (PK/PD) Interaction After co-Administration of Cilostazol With Ginkgo Biloba or Placebo
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: Cilostazol, Ginkgo biloba and placebo
- Registration Number
- NCT00689858
- Lead Sponsor
- SK Chemicals Co., Ltd.
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 40
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Cilostazol, Ginkgo biloba and placebo Period 1: Cilostazol, Ginkgo biloba Period 2:Cilostazol, placebo 2 Cilostazol, Ginkgo biloba and placebo Period 1: Cilostazol, placebo Period 2: Cilostazol, Ginkgo biloba
- Primary Outcome Measures
Name Time Method Maximum plasma concetration of Cilostazol at steady state within 12hrs after cilostazol
- Secondary Outcome Measures
Name Time Method PD parameter: change from baseline after administration (change value of aggregation %) within 12hrs after cilostazol
Trial Locations
- Locations (3)
INJE University Pusan Paik Hospital
🇰🇷Pusan, Korea, Republic of
SK chemicals
🇰🇷Seoul, Korea, Republic of
SKChemicals
🇰🇷Seoul, Korea, Republic of