NCT01039896已完成1 期
An Open-label, Randomized, Crossover Study to Evaluate the Safety and Pharmacokinetics After Multiple Administration of SLM0807 Alone and Multiple Co-administration of HKB0701/SLM0807 in Korean Healthy Subjects
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
- 24
- 主要终点
- Css,max and AUCinf
研究概览
简要总结
The aim of this study is to assess whether HKB0701 alters pharmacokinetics of SLM0807.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers who are in age range of 20-50years and the weight range is not exceed ±20% of ideal weight. Ideal weight = [height -100]*0.9
- •Subjects with no history of any significant chronic disease
- •Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data
- •Available for the entire study period
- •Willing to adhere to protocol requirements and sign a informed consent form.
排除标准
- •Subjects who have taken any drugs to induce or inhibit hepatic enzyme activity within 30days prior to drug administration
- •Subjects who have symptom of an acute illness within 4 weeks prior to drug administration
- •Subjects with a history of clinically significant allergies including drug allergies
- •Subjects whose clinical laboratory test values are outside the accepted normal range(Especially,AST or ALT >1.25 times to normal range or total bilirubin > 1.5times to normal range)
- •Subjects with a history of drug, caffeine or alcohol abuse (caffeine drink >5cups /day, alcohol >30g/day)
- •Heavy smoker ( >10cigarettes/day)
- •Subjects who have had a diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice)
- •Subjects who have donated plasma within 60days prior to drug administration
- •Subjects who have participated in a clinical study within 90days prior to drug administration
- •Subjects who have received any drugs that might confound the results of the trial in the opinion of principal investigator (cimetidine within 7days prior to drug administration)
- •Female subjects who are pregnant, breastfeeding or not using medically acceptable birth control
研究组 & 干预措施
Group2
Experimental
SLM0807 and HKB0701
干预措施: Period I : HKB0710 and SLM0807, Period II : SLM0807 (Drug)
Group1
Experimental
SLM0807
干预措施: Period I : SLM0807, Period II : HKB0701 and SLM0807 (Drug)
结局指标
主要结局
Css,max and AUCinf
时间窗: up to 24hrs
次要结局
- AUCtau, AUCt, Tmax(up to 24hrs)
研究者
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