NCT01341249已完成1 期
Clinical Trial to Compare the Pharmacokinetic Profiles of DW224aa (Aspartate) Tablet and DW224a (Hydrochloride) Capsule After a Single Oral Administration 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
- 32
- 试验地点
- 1
- 主要终点
- Cmax of zabofloxacin in plasma
研究概览
简要总结
The purpose of this study is to compare and explore pharmacokinetics of zabofloxacin, the main component of DW224aa(Test drug) and DW224a(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 45 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 45 years old at the time of screening
- •one with weight of more than 55kg, in the range of IBW 20%
- •IBW(kg)={height(cm)-100}*0.9
- •one 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 who is allergic or has clinically significant allergic history to the quinolone antibiotics, or to other drugs(Aspirin, antibiotics, etc)
- •one who shows the following result in clinical laboratory test: AST,ALT>1.25 times of the upper limit of normal range
- •one who has confirmed positive at serological tests (HBs antigen, HCV antibody and HIV antibody)
- •one who has drug abuse history or positive result at urine screening tests (cannabinoid, opioid, amphetamine, cocaine, barbiturate, benzodiazepine)
- •one who has taken any prescribed drugs, herbal agents or crude drugs within 2 weeks before study drug administration, or who has taken any over-the-counter (OTC) drugs or vitamins (Investigators will determine his eligibility by considering the effect of the drug on his safety or pharmacokinetic results in case other inclusion/exclusion criteria is satisfied.)
- •one who has participated in other clinical study within 2 months before study drug administration
- •one who donated whole blood within 2 months or component blood within 1 month or who are donated within 1 month before the treatment
- •one who drank Over 21 units/week of alcohol or subjects who would not be able to stop drinking alcohol during the hospitalization
- •one who are Heavy smoker more than 10 cigarettes/day within 3 months prior to screening or subjects who would not be able to stop smoking during the hospitalization
- •one who had a beverage containing caffeine, drank alcohol, or smoked within 48hrs before the hospitalization or who had a beverage containing grapefruits during the hospitalization
- •one with clinically significant observations considered as unsuitable based on medical judgment by investigators
研究组 & 干预措施
DW224aa
Experimental
DW224aa given by oral administration
干预措施: Experimental DW224aa (Drug)
DW224a
Active Comparator
DW224aa given by oral administration
干预措施: Experimental DW224a (Drug)
结局指标
主要结局
Cmax of zabofloxacin in plasma
时间窗: Up to 48
AUClast of zabofloxacin in plasma
时间窗: Up to 48
次要结局
- Tmax of zabofloxacin in plasma(Up to 48h)
- terminal half-life (t1/2) of zabofloxacin in plasma(Up to 48h)
- CL/F of zabofloxacin in plasma(Up to 48h)
研究者
研究点 (1)
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