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

SK chemicals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Cilostazol, Ginkgo biloba and placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00689858

GETC_DDI_I_2008

Details and patient eligibility

About

TO assess the PK/PD effect of co-administerd Cilostazol with Ginkgo biloba or placebo, Phase I study in healthy Volunteers were designed

Enrollment: 40 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

1

Experimental group

Description:

Period 1: Cilostazol, Ginkgo biloba Period 2:Cilostazol, placebo

Treatment:

Drug: Cilostazol, Ginkgo biloba and placebo

2

Active Comparator group

Description:

Period 1: Cilostazol, placebo Period 2: Cilostazol, Ginkgo biloba

Treatment:

Drug: Cilostazol, Ginkgo biloba and placebo