Study to Assess the Effect of Pharmacokinetics/Pharmacodynamics (PK/PD) Interaction After co-Administration of Cilostazol With Ginkgo Biloba or Placebo
TO assess the PK/PD effect of co-administerd Cilostazol with Ginkgo biloba or placebo, Phase I study in healthy Volunteers were...
Brief Summary
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.”
TO assess the PK/PD effect of co-administerd Cilostazol with Ginkgo biloba or placebo, Phase I study in healthy Volunteers were designed
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
- Study Primary Completion Date: July 2008
Intervention(s) in this Clinical Trial
- Drug: Cilostazol, Ginkgo biloba and placebo
- dosing time
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Period 1: Cilostazol, Ginkgo biloba Period 2:Cilostazol, placebo
- Active Comparator: 2
- Period 1: Cilostazol, placebo Period 2: Cilostazol, Ginkgo biloba
Outcome Measures for this Clinical Trial
Primary Measures
- Maximum plasma concetration of Cilostazol at steady state
- Time Frame: within 12hrs after cilostazol
Safety Issue?: No
- Time Frame: within 12hrs after cilostazol
Secondary Measures
- PD parameter: change from baseline after administration (change value of aggregation %)
- Time Frame: within 12hrs after cilostazol
Safety Issue?: No
- Time Frame: within 12hrs after cilostazol
Criteria for Participation in this Clinical Trial
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 Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 19 Years
Maximum Age for this Clinical Trial: 45 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: SK Chemicals Co.,Ltd. Industry
Overall Clinical Trial Officials and Contacts
Jae Gook Shin, MD,PhD Principal Investigator Inje University
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00689858
Study ID Number: GETC_DDI_I_2008
ClinicalTrials.gov Identifier: NCT00689858
Health Authority: Korea: Food and Drug Administration
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00689858
