NCT01094847已完成1 期
Clinical Trials to Compare Mosapride Bioavailability Between DWJ1252 and Mosapride Medicine
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年4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
- 30
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of Mosapride
研究概览
简要总结
The purpose of this study is to compare and explore bioavailability of mosapride, the main component of DWJ1252(Test drug) and mosapride medicine(Reference drug).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •a healthy adult male within the range of 20 to 50 years old at the time of screening
- •with weight of more than 55kg, in the range of IBW 20%: IBW(kg)={height(cm)-100}*0.9
- •who understood completely about this study after the detailed explanation is given, decided to volunteer and gave written informed consent to participate in study in compliance with the requirement of the entire protocol.
排除标准
- •one with clinically significant disease in liver, kidney, nerve system, respiratory system, endocrine system, blood, tumor, urinary system, cardiovascular system, mental disease or with medical history
- •one with gastrointestinal disease or with gastrointestinal surgical history which can affect the absorption of the investigational drug.
- •one with genetic disease like galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •one who is allergic or has clinically significant allergic history to the component of the investigational drug (mosaprisde), and any component from same family, or to other drugs(Aspirin, antibiotics, etc)
- •one who shows different rhythm than sinus rhythm in screening, like QTc >450ms on electrocardiogram, PR interval>200msec or QRS interval 120>msec
- •one who shows the following result in clinical laboratory test: AST,ALT>1.25 times of the upper limit of normal range
- •one who shows vital signs with the number of systolic blood pressure of 160 mmHg or 100 mmHg, and the number of diastolic blood pressure of 95mmHg or 60mmHg
研究组 & 干预措施
Treatment A
Experimental
DWJ1252 given by oral administration under fasting conditions
干预措施: DWJ1252 (Drug)
Treatment B
Active Comparator
DWJ1252 given by oral administration, 30 minutes after a meal
干预措施: DWJ1252 (Drug)
结局指标
主要结局
Pharmacokinetics of Mosapride
时间窗: 48hr after 1st administration
AUC(0-last), Cmax
次要结局
- Pharmacokinetics of mosapride, M-1(48hr after 1st administration)
研究者
研究点 (1)
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