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
Summary
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 %)
Eligibility
Minimum age: 19 Years.
Maximum age: 45 Years.
Gender(s): Male.
Criteria:
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
|