NCT01663038已完成1 期
Comparative Pharmacokinetics of Clopidogrel 75mg and Aspirin 100mg After Single Oral Administration as a Fixed Dose Combination Versus Separate Combination in Healthy Male Volunteers
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
- 60
- 试验地点
- 1
- 主要终点
- Cmax of clopidogrel/acetylsalicylic acid
研究概览
简要总结
The purpose of this study is to compare pharmacokinetics between fixed-dose combination and separate combination of clopidogrel 75mg/aspirin 100mg.
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
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •A healthy male volunteer aged 20 to 55, and within 20% of ideal body weight.
- •Have not any congenital or chronic diseases and medical symptom.
- •Appropriate subject for the study judging from examinations(interview, vital signs, 12-lead ECG, physical examination, blood, urinalysis result on screening.
- •Able to participate in the entire trial.
- •Signed the informed consent form prior to study participation.
排除标准
- •Take metabolic enzyme inducing or inhibiting drugs like barbiturates within 28 days prior to the first IP administration.
- •show evidence of acute disease within 28 days prior to the first IP administration.
- •Have the medical history of bleeding symptom or bleeding disease
- •Have the disease history(ex. Inflammatory intestinal disease, stomach or duodenum ulcer, liver and bowels disease, appendectomy except of gastrointestinal surgery history) that may influence on the absorption, distribution, metabolism and excretion of the drug.
- •Have relevant hypersensitivity against drug or clinically significant allergic diseases except mild rhinitis that does not need medication.
- •Have hypersensitivity reaction histories for Clopidogrel or aspirin.
- •Have abnormal laboratory result. AST or ALT > 1.25 times of upper limit/ Total bilirubin > 1.5 times of upper limit/ PT, aPTT, BT over upper limit/ Platelet count <150X10^9/L or >350X10^9/L
- •A drug abuse or a heavy caffeine consumer (more than 5cups per a day) or a heavy smoker (more than 10 cigarettes per a day) or a regular alcohol consumer(more than 30g/day) or drinking within 7days prior to the first IP administration.
- •Have a diet(Especially, grapefruit juice-within 7days prior to the first IP administration) that may influence on the absorption, distribution, metabolism and excretion of the drug(s).
- •Have donated whole blood within 60 days prior to the first IP administration.
- •Participated in the other clinical trials within 90days prior to the first IP administration.
- •Take medicine which affect to this trial within 10 days prior to the first IP administration.
- •Appropriate subject for the trial judging from principal investigator.
研究组 & 干预措施
Clopidogrel and Aspirin
Active Comparator
干预措施: Clopidogrel (Drug)
Clopidogrel and Aspirin
Active Comparator
干预措施: Aspirin (Drug)
Copidogrel
Experimental
干预措施: Fixed dose combination of clopidogrel/Aspirin (Drug)
结局指标
主要结局
Cmax of clopidogrel/acetylsalicylic acid
时间窗: Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h
AUC of clopidogrel/acetylsalicylic acid
时间窗: Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h
次要结局
- Assess Cmax of salicylic acid.(Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h)
- Assess AUC of salicylic acid.(Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h)
研究者
研究点 (1)
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