An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetics After Administration of CJ30001 and Co-administration of HKB0701/SLM0807 in Korean Healthy Subjects

HK inno.N Corporation0 个研究点目标入组 30 人开始时间: 2009年10月最近更新: 2011年6月10日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: HK inno.N Corporation
入组人数: 30
主要终点: Geometric mean Cmax

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The objective of this study is to demonstrate the bioequivalence of CJ30001(fixed-dose combination tablet of HKB0701 and SLM0807) relative to HKB0701 and SLM0807 co-administered to healthy subjects.

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 50 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 abuse(caffeine drink >5cups/day)
•Subjects with a history of alcohol abuse(alcohol>30g/day) or who have ever drinked alcohol whinin 7days prior to drug administration
•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 within 10days prior to drug administration (cimetidine within 7days prior to drug administration)
•Female subjects who are pregnant, breastfeeding or not using medically acceptable birth control

结局指标

主要结局

Geometric mean Cmax

时间窗: up to 24hrs

Geometric mean AUCt

时间窗: up to 24hrs

次要结局

未报告次要终点

研究者

发起方

HK inno.N Corporation

申办方类型

Industry

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