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

Clinical Trial to Assessment the PK/PD Characteristics and Safety After co-Administration of Cilostazol With Ginkgo Biloba or Placebo in Healthy Subject.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00689858

Enrollment

Registered

2008-06-04

Start date

2007-05-31

Completion date

2008-07-31

Last updated

2009-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy volunteers

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

Interventions

DRUGCilostazol, Ginkgo biloba and placebo

dosing time

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

19 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Maximum plasma concetration of Cilostazol at steady state	within 12hrs after cilostazol

Secondary

Measure	Time frame
PD parameter: change from baseline after administration (change value of aggregation %)	within 12hrs after cilostazol

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026