NCT00689858已完成1 期
Clinical Trial to Assessment the PK/PD Characteristics and Safety After co-Administration of Cilostazol With Ginkgo Biloba or Placebo in Healthy Subject.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Maximum plasma concetration of Cilostazol at steady state
研究概览
简要总结
TO assess the PK/PD effect of co-administerd Cilostazol with Ginkgo biloba or placebo, Phase I study in healthy Volunteers were designed
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.]
排除标准
- •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.
研究组 & 干预措施
1
Experimental
Period 1: Cilostazol, Ginkgo biloba Period 2:Cilostazol, placebo
干预措施: Cilostazol, Ginkgo biloba and placebo (Drug)
2
Active Comparator
Period 1: Cilostazol, placebo Period 2: Cilostazol, Ginkgo biloba
干预措施: Cilostazol, Ginkgo biloba and placebo (Drug)
结局指标
主要结局
Maximum plasma concetration of Cilostazol at steady state
时间窗: within 12hrs after cilostazol
次要结局
- PD parameter: change from baseline after administration (change value of aggregation %)(within 12hrs after cilostazol)
研究者
研究点 (3)
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