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Study to Investigate the Effect of Food on the Pharmacokinetics/Pharmacodynamics and Safety of CKD-519(CKD-519 FDI)

2015年12月4日 更新者:Chong Kun Dang Pharmaceutical

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

The purpose this study investigate the effect of food on the pharmacokinetics/pharmacodynamics and safety of CKD-519

研究概览

研究类型

介入性

注册 (实际的)

45

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Seodaemun-gu
      • Seoul、Seodaemun-gu、大韩民国、120-752
        • Severance Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

19年 至 55年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Between 19 aged and 55 aged in healthy adult
  2. Body weight more than 55kg in male, 50kg in female
  3. Body Mass Index more than 18.5 and under 25(body mass index=kg/m2)
  4. 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)
  5. 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
  6. 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:

  1. 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.
  2. Have a gastrointestinal disease history that can effect drug absorption(Crohn's disease, ulcers, etc.) or surgery(except simple appendectomy or hernia surgery)
  3. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of drugs or additives.
  4. 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.
  5. 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
  6. Sitting SBP(Systolic Blood Pressure )>150 mmHg or <90 mmHg, sitting DBP(Diastolic Blood Pressure )>100 mmHg or 50 mmHg , after 5 minutes break.
  7. Drug abuse or have a history of drug abuse shows a positive for urine drug test.
  8. Pregnant or lactating women.
  9. A heavy caffeine consumer(caffeine>5 cups/day), alcohol consumer(alcohol>210g/week), or smoker(cigarette>10 cigarettes/day)
  10. 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
  11. Subject who takes inhibitor and inducers of drug metabolizing enzyme(Barbiturates etc.) within 30days.
  12. 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)
  13. Subject who treated with any investigational drugs within 90 days before the beginning of study treatment.
  14. Previously donate whole blood within 60 days or component blood within 30days.
  15. An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
  16. Positive for Serology test(Hepatitis B, Hepatitis C, HIV)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
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

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

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

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

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

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
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
0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
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
0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
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
0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
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
0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
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
0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
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
0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
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
0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168

次要结果测量

结果测量
大体时间
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
0(predose), 1, 2, 4, 6, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年6月1日

初级完成 (实际的)

2015年8月1日

研究完成 (实际的)

2015年8月1日

研究注册日期

首次提交

2015年6月7日

首先提交符合 QC 标准的

2015年6月24日

首次发布 (估计)

2015年6月29日

研究记录更新

最后更新发布 (估计)

2015年12月7日

上次提交的符合 QC 标准的更新

2015年12月4日

最后验证

2015年12月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 148FDI15009

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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