Study to Investigate the Effect of Food on the Pharmacokinetics/Pharmacodynamics and Safety of CKD-519(CKD-519 FDI)
A Randomized, Open-label, Single Dose, 3-treatment, 3-period, 6-sequence Crossover Study to Investigate the Effect of Food on the Pharmacokinetics/Pharmacodynamics and Safety of CKD-519 After Oral Administration in Healthy Adult Volunteers
研究概览
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Seodaemun-gu
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Seoul、Seodaemun-gu、大韩民国、120-752
- Severance Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Between 19 aged and 55 aged in healthy adult
- Body weight more than 55kg in male, 50kg in female
- Body Mass Index more than 18.5 and under 25(body mass index=kg/m2)
If female, must include more than one among the items
- The menopause(there is no natural menses for at least 2 years)
- Surgical Infertility(hysterectomy or bilateral oophorectomy, tubal ligation or other methods of infertility condition)
- If men has sexual life with women of childbearing age, Necessarily he agrees that use condoms and do not sperm donation until two months during clinical trials and after the final dosage of investigational products
- Those who fully understand about this clinical trials after enough hearing, and then decided to join the clinical trials by themselves and to comply with the precautions written consent
Exclusion Criteria:
- Have clinically significant disease that hepatobiliary system(severe hepatic impairment, etc.), kidney(severe renal impairment, etc.), nervous system, immune system, respiratory system, endocrine system, haemato-oncology disease, cardiovascular system(heart failure, etc.) or mental illness, or a history of mental disease.
- Have a gastrointestinal disease history that can effect drug absorption(Crohn's disease, ulcers, etc.) or surgery(except simple appendectomy or hernia surgery)
- Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of drugs or additives.
- An impossible one who participates in clinical trial including screening tests (medical history taking, BP, 12-lead ECG, physical examination, blood&urine laboratory test result) before 28 days the taking investigational products.
Defined by the following laboratory parameters
- AST(Aspartate aminotransferase), ALT(Alanine aminotransferase)>1.25* upper limit of normal range
- Total bilirubin>1.5* upper limit of normal range
- CPK(Creatine phosphokinase)>1.5* upper limit of normal range
- eGFR(Estimated Glomerular Filtration Rate, using by MDRD(Modification of Diet in Renal Disease) method)<60 mL/min/1.73m2
- Sitting SBP(Systolic Blood Pressure )>150 mmHg or <90 mmHg, sitting DBP(Diastolic Blood Pressure )>100 mmHg or 50 mmHg , after 5 minutes break.
- Drug abuse or have a history of drug abuse shows a positive for urine drug test.
- Pregnant or lactating women.
- A heavy caffeine consumer(caffeine>5 cups/day), alcohol consumer(alcohol>210g/week), or smoker(cigarette>10 cigarettes/day)
- Subject takes ethical drug or herbal medicine within 14 days, OTC(Over The Counter Drug) within 7 days before the beginning of study treatment but investigator determine that the taking drug affect this study or could affect the safety of subjects
- Subject who takes inhibitor and inducers of drug metabolizing enzyme(Barbiturates etc.) within 30days.
- Taking foods containing grapefruit within 7 days before the beginning of study treatment(ex. Drinking containing grapefruit of 1 liter per a day or more within 7days before the beginning of study treatment)
- Subject who treated with any investigational drugs within 90 days before the beginning of study treatment.
- Previously donate whole blood within 60 days or component blood within 30days.
- An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
- Positive for Serology test(Hepatitis B, Hepatitis C, HIV)
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Group 1
CKD-519 200mg administration, subjects have a Fasting, Standard Meal, High Fat Meal by randomized group. Fasting→Standard Meal→High Fat Meal |
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实验性的:Group 2
CKD-519 200mg administration, subjects have a Fasting, Standard Meal, High Fat Meal by randomized group. Standard Meal→High Fat Meal→Fasting |
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实验性的:Group 3
CKD-519 200mg administration, subjects have a Fasting, Standard Meal, High Fat Meal by randomized group. High Fat Meal→Fasting→Standard Meal |
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实验性的:Group 4
CKD-519 200mg administration, subjects have a Fasting, Standard Meal, High Fat Meal by randomized group. Fasting→High Fat Meal→Standard Meal |
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实验性的:Group 5
CKD-519 200mg administration, subjects have a Fasting, Standard Meal, High Fat Meal by randomized group. Standard Meal→Fasting→High Fat Meal |
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实验性的:Group 6
CKD-519 200mg administration, subjects have a Fasting, Standard Meal, High Fat Meal by randomized group. High Fat Meal→Standard Meal→Fasting |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Cmax of CKD-519
大体时间:0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
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0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
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Area under the plasma drug concentration-time curve(AUC0-last) of CKD-519
大体时间:0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
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0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
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AUC0-∞ of CKD-519
大体时间:0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
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0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
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Tmax of CKD-519
大体时间:0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
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0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
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T1/2 of CKD-519
大体时间:0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
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0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
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CL/F(Clearance/Bioavailability) of CKD-519
大体时间:0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
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0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
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Vd/F of CKD-519
大体时间:0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
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0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
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次要结果测量
结果测量 |
大体时间 |
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Inhibition of CETP(Cholesteryl ester transfer protein) Activity
大体时间:0(predose), 1, 2, 4, 6, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
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0(predose), 1, 2, 4, 6, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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