NCT01332890已完成1 期
A Randomized, Open-label, Multiple-dose, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Revaprazan and Itopride HCl in Healthy Male Subjects
Yuhan Corporation1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年4月最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pharmacokinetics
研究概览
简要总结
To evaluate drug-drug interaction
详细描述
The main objective is to evaluate the pharmacokinetic profile of the 50mg Revaprazan plus 50mg Itopride compared to 50mg Revaprazan or 50mg Itopride alone in healthy Korean subjects
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males aged 20 to 50 years old, with a body mass index (BMI) between 19 and 27 kg/m2
- •Acceptable medical history, physical exam,laboratory tests and EKG, during screening
- •Eligible for blood sampling during study period
- •Provision of signed written informed consent
排除标准
- •History of any clinically significant disease
- •History of drug/chemical/alcohol abuse
- •Clinically significant illness or within 30days before the first dose
- •Use of medication known to chronically alter drug absorption or elimination processes within 30days before the first dose of investigational product
- •Use of prescribed medication during the 14 days before administration of the first dose of investigational product
- •Use of any non-prescribed medication during the 7 days before administration of the first dose of investigational product - Use of any oriental medication medication during the 30 days before administration of the first dose of investigational product
- •Participated in a clinical study involving administration of an investigational drug (new chemical entity) or a marketed drug within past 90 days
- •Consuming more than 21 units of alcohol per week
- •Smoking more than 20 cigarettes per day or consuming more than 5 cups of caffeinated beverages.
结局指标
主要结局
Pharmacokinetics
时间窗: Blood sampling will be obtained on day 7 at each period.
Serum for each treatment period Experimental. AUCtau, Cmax will be estimated using non-compartmental analysis.
次要结局
未报告次要终点
研究者
研究点 (1)
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