Clinical Study to Assess the Effect of Food on the Pharmacokinetic Characteristics of CKD-501 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- To evaluate the pharmacokinetics of CKD-501 1mg (fed vs. fasting)
研究概览
简要总结
The purpose of this study is to assess the effect of food on the pharmacokinetic characteristics of CKD-501 in healthy subject.
And, secondarily, pharmacokinetic characteristics of the main metabolites will be identified.
详细描述
Healthy volunteers are administrated single-dose (CKD-501 1mg), two treatment(fed vs. fasting), two-period, two sequence crossover.
Every time before and after each medication, PK parameters and safety of CKD-501 1mg is performed using a blood sample and conducting some tests respectively.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Between 20 aged and 45 aged in healthy adults
- •Weight more than 45kg, IBW 20% within the range
- •Agreement with written informed consent
排除标准
- •Subject has symptoms of acute disease within 28 days of starting administration of investigational drug
- •Subject with known for history(such as inflammatory gastrointestinal disease, gastric or duodenal ulcer, liver diseases and so on) with affect the ADME of drug
- •Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, endocrine system, blood system, digestive system, central nervous system, mental disease or malignancy disease
- •Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test) within 28 days of starting administration of investigational drug
- •Inadequate result of laboratory test
- •AST(SGOT) or ALT(SGPT) > 1.25 x upper limit of normal range
- •Total bilirubin > 1.5 x upper limit of normal range
- •Clinically significant allergic disease(Except for mild allergic rhinitis seems to be not need for medication)
- •Subject with known for hypersensitivity reactions to glitazone
- •Previously participated in other trial within 60 days
- •Treatment with dug-medicated induction/inhibition metabolic enzyme such as barbiturates within 1 month or with may affect the clinical trial within 10 days
- •Subject takes an abnormal meal which affect the ADME of drug
- •Not able to taking the institutional standard meal
- •Previously make whole blood donation within 60 days or component blood donation within 20 days
- •Continued to be taking caffeine (caffeine > 5 cup/day), drinking(alcohol > 30 g/day) or during clinical trials can not be drunk or severe heavy smoker (cigarette > 10 cigarettes per day)
- •An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result
- •Subject who not practice contraception during clinical trial or pregnant women(including positive pregnancy test) or nursing mothers
研究组 & 干预措施
CKD-501 1mg (fed-fasted group)
CKD-501 1mg should be administered following a high-fat, high-caloric diet(fed condition) in one period and on an empty stomach(fasting condition) in the other period.
干预措施: CKD-501 1mg (Drug)
CKD-501 1mg (fasted-fed group)
CKD-501 1mg should be administered on an empty stomach(fasting condition) in one period and following a high-fat, high-caloric diet(fed condition) in the other period.
干预措施: CKD-501 1mg (Drug)
结局指标
主要结局
To evaluate the pharmacokinetics of CKD-501 1mg (fed vs. fasting)
时间窗: 0-48 hrs
次要结局
- To evaluate the safety of CKD-501 1mg from vital signs, physical exam, ECG, laboratory test, adverse event and so on(Throughout the trial)