NCT01520012已完成1 期
Clinical Trial to Investigate the Influence of Food on Safety/Tolerability and Pharmacokinetics of YH4808 After Oral Administration in Healthy Male Subjects
Yuhan Corporation1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2012年2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
- Area under the plasma concentration versus time curve of YH4808
研究概览
简要总结
The main objective is to evaluate the food effect on the pharmacokinetic profile of YH4808 100 mg b.i.d and YH4808 300 mg after oral administration in healthy male 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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects who signed written consent after receiving thorough explanation on trial purpose, content, and characteristics of investigational drug
- •Healthy male volunteers in the age between 20 to 45 years old
- •Weight: over 50kg, within ±20% of ideal body weight
- •Subjects who were determined to be appropriate through screening
排除标准
- •Clinically significant disorder in liver, kidney, cardiovascular, respiratory system, endocrine system and CNS in the physical examination and clinical laboratory tests or a medical history of malignant tumor or psychological disease
- •Medical history of gastrointestinal disease or acid restraining surgery, gastric/esophagus surgery (excluding appendectomy, hernia surgery)
- •A history of hypersensitivity to drugs or clinically significant allergic disease
- •Clinically significant abnormal values in blood chemistry(≥ 1.5 fold of normal upper limit in the levels of SGOT, SGPT)
- •Subjects who had a history of drug abuse or who had a positive results on urine drug screening
- •Subjects who had taken usual dose of any prescription drugs within 14 days before the treatment or who had used usual dose of OTC drugs within 7 days before the treatment(cf, be able to be enrolled in this study according to an investigatory consideration)
- •Subjects who participated in another clinical trial within 2 months before enrolling in this study
- •Subjects who donated whole blood within 2 months or component blood within 1 month or who are donated within 1 month before the treatment
- •Subjects who drank Over 21 units/week of alcohol or subjects who were unable to stop drinking alcohol during the hospitalization
- •Subjects who stopped smoking within 3 months before the treatment
- •Subjects who had a beverage containing grapefruits within 24hrs before the hospitalization or who had a beverage containing grapefruits during the hospitalization
- •Subjects who had a beverage containing caffeine during the hospitalization
- •Subjects with clinically significant observations considered as unsuitable based on medical judgment by investigators
研究组 & 干预措施
Sequence 1
Experimental
干预措施: YH4808 100 mg (Drug)
Sequence 2
Experimental
干预措施: YH4808 100 mg (Drug)
Sequence 3
Experimental
干预措施: YH4808 300 mg (Drug)
Sequence 4
Experimental
干预措施: YH4808 300 mg (Drug)
Sequence 5
Experimental
干预措施: YH4808 300 mg (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve of YH4808
时间窗: Blood sampling during 24 or 48 hrs after administration
non-compartmental analysis
Peak plasma concentration of YH4808
时间窗: Blood sampling during 24 or 48 hrs after administration
non-compartmental analysis
次要结局
- Time to reach peak plasma concentration of YH4808(Blood sampling during 24 or 48 hrs after administration)
研究者
研究点 (1)
Loading locations...
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