NCT01422109已完成1 期
Comparative Pharmacokinetics After Single Oral Administration of YH14659, a Fixed Dose Combination Versus Coadministration of Separate Constituents in Healthy Male Volunteers
Yuhan Corporation1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2011年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration(Cmax) of clopidogrel
研究概览
简要总结
The objective of this study is to compare pharmacokinetics after single oral administration of 2 capsules of YH14659, a fixed-dose combination of clopidogrel and aspirin developed by Yuhan Corporation versus co-administration of Plavix (clopidogrel) and Astrix (aspirin) in healthy male volunteers.
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
- •The patient or legally authorized representative must sign a written informed consent, prior to the any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug
- •Healthy male volunteers of aged between 20 years to 55 years
- •Have standard weight of ≤ ±20% based on Broca index* (Broca index: ideal weight(kg) = (height(cm)-100) x 0.9)
- •Have no history of neither congenital nor chronic disease
- •Have no history of abnormal symptoms or opinions as a result of physical examination (medical checkup)
- •Eligible subjects with acceptable medical history, physical examination laboratory tests, ECG during screening period
排除标准
- •Received any drug that induce or/and inhibit drug metabolizing enzyme such as barbital within the last 28 days prior to the first administration
- •Shown symptoms doubtful as an acute disease within the last 28 days prior to the first administration
- •Have signs of bleeding symptoms or/and history of disease such as: gum bleeding, hard to control hemorrhage, easily suffer from bruise, and etc.
- •Have disease that can affect absorption, distribution, metabolism and excretion of the drug such as: inflammatory bowel disease, gastric ulcer, duodenal ulcer, hepatic disorders, and gastrointestinal tract surgery except appendectomy
- •Have a known allergy(except mild allergic rhinitis which does not require treatment) or hypersensitivity to drugs
- •Have the following abnormal findings on diagnosis;
- •have AST or ALT > 1.25 times of normal upper limit
- •have total bilirubin > 1.5 times of normal upper limit
- •have higher PT, aPPT, BT than normal range
- •have PLT below 150,000 or above 350,000
- •Have been drug abuse, excessive caffeine (> 5 cups/day), heavy smoking (>10 cigarettes/day), continuous alcohol intake (> 30g/day) or have drunk within the last 7 days prior to the first administration
- •Have been on a diet that can affect absorption, distribution, metabolism and excretion of the drug (especially grapefruit juice 7 days prior to the first administration)
- •Donated blood within 60 days prior to the first administration
- •Participated in any other clinical trials within 60 days prior to the first administration
- •Have used any drug which is thought to affect this study by principal investigator 10 days prior to the first administration
- •Subject who is judged to be ineligible by principal investigator or sub-investigator
研究组 & 干预措施
Group A
Experimental
干预措施: YH14659 (Drug)
Group B
Active Comparator
干预措施: clopidogrel & aspirin (Drug)
结局指标
主要结局
Maximum plasma concentration(Cmax) of clopidogrel
时间窗: 14 days
Area under the time-concentration curve to last concentration(AUCt) of clopidogrel
时间窗: 14 days
Maximum plasma concentration(Cmax) of acetylsalicylic acid
时间窗: 14 days
Area under the time-concentration curve to last concentration(AUCt) of acetylsalicylic acid
时间窗: 14 days
次要结局
- Cmax of salicylic acid, the major active metabolite of aspirin(14 days)
- AUCt of salicylic acid, the major active metabolite of aspirin(14 days)
研究者
研究点 (1)
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