Pharmacokinetics, Safety and Tolerability of CKD-387 10/500mg BE Phase1
2019年11月6日 更新者:Chong Kun Dang Pharmaceutical
An Open-label, Rendomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-387 in Healthy Subjects.
The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of CKD-387
研究概览
地位
完全的
条件
详细说明
An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-387 in helalthy subjects.
研究类型
介入性
注册 (实际的)
58
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
-
-
Seongbuk-Gu
-
Seoul、Seongbuk-Gu、大韩民国
- Korea University Anam 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 45年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Healthy adult older than 19 years and less than 45 years at the time of screening.
- BMI 18.5~29.9 kg/m2 and body weight more than 50kg.
- Subjects who have consented to the use of appropriate double- pregnancy contraceptive methods up to one months after the last investigational product and not to provide sperm for men.
- Subjects who sign on an informed consent form willingly.
Exclusion Criteria:
- Subjects who have a clinically significant disease or medical history such as respiratory, hepatic, kidneys, blood, gastrointestinal, endocrine, immune system, skin, nervous and mental disease.
- Subjects who have acute disease within 28 days prior to the first administration.
- Subjects who have history that may affect the ADME.
- Subjects who have medical history or medical abuse history of hypersensitivity from SGLT inhibitors or Biguanides including Metformin or other medications(Aspirin, Antibiotics etc.).
- Subjects who have clinically significant chronic disease.
- Subjects with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose mal-absorption.
Subjects whose laboratory test result are same as below;
- AST,ALT > UNL(Upper Normal Limit)x3
- Fasting glucose level out of 70-125mg/dl
- Creatinine clearance is lower than 80mL/min which is calcuated by Cockcroft-Gault formulation.
- QT>450msec
- Positive urine hCG(female).
Subjects whoes blood pressure exceeds out of normal range as below at screening.
- SBP : over 100mmHg, under 160mmHg
- DBP : over 60mmHg, under 100mmHg
- Subjects who have been found to be positive in serological tests(HBs antigen, HCV antibody and HIV antibody).
- Subjects who took ETC(Ethical Drug), oriental medicine within 2 weeks prior to the first administration of investigational products.
- Subjects who took OTC(Over-the-counter Drug, including korean galenical drug) within 10 days prior to the first administration of investigational products.
- Subjects who have allergic disease which has clinical significance(But, light allergic rhinitis and ligth allergic dermatitis which do not need medication is exceptional).
- Subjects who can not eat standard meals provided by the institution.
- Subjects who donated whole blood within 60 days, donated the blood components within 20 days prior to the first administration of investigational products.
- Subjects who received blood transfusion within 30 days prior to the first administration of investigational products.
- Subjects who were participated in the other clinical trial within 90 days prior to the first administration of investigational products.
- Subjects who took medication for the induction and inhibition of metabolizing enzymes such as barbiturate drugs within 6months prior to the first administration of investigational products.
- Subjects who have had abnormal diets that can affect the ADME of the drug within 30 days prior to the first administration of investigational products. (Ingestion of grapefruit juice>1L/day or Caffein>5Cups/day).
- Subjects who have took regular alcohol(alcohol>30g/day) prior to the first administration of investigational products.
- Subjects who smoked more than 10 cigarettes per day prior 3months to the first administration of investigational products or cannot discontinue smoking during the clinical trial.
- Subjects who is determined unsuitable to participate in this clinical trial by the investigator.
- Lactating Women.
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:其他
- 分配:随机化
- 介入模型:并行分配
- 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:PartA, Treatment-1
Period 1 : Reference drug Period 2 : Test drug
|
Once a day.
Under fasting condition
其他名称:
|
实验性的:PartA, Treatment-2
Period 1 : Test drug Period 2 : Reference drug
|
Once a day.
Under fasting condition
其他名称:
|
实验性的:PartB, Treatment-1
Period 1 : Reference drug Period 2 : Test drug
|
Once a day.
Under fed condition
其他名称:
|
实验性的:PartB, Treatment-2
Period 1 : Test drug Period 2 : Reference drug
|
Once a day.
Under fed condition
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Part A : Cmax under fasting condition
大体时间:0(predose)~48 hours
|
Maximum concentration of the dapagliflozin
|
0(predose)~48 hours
|
Part A : Cmax under fasting condition
大体时间:0(predose)~48 hours
|
Maximum concentration of the metformin
|
0(predose)~48 hours
|
Part A : AUClast under fasting condition
大体时间:0(predose)~48 hours
|
Area Under Curve(last) of the dapagliflozin
|
0(predose)~48 hours
|
Part A : AUClast under fasting condition
大体时间:0(predose)~48 hours
|
Area Under Curve(last) of the metformin
|
0(predose)~48 hours
|
Part B : Cmax under fed condition
大体时间:0(predose)~48 hours
|
Maximum concentration of the metformin
|
0(predose)~48 hours
|
Part B : AUClast under fed condition
大体时间:0(predose)~48 hours
|
Area Under Curve(last) of the metformin
|
0(predose)~48 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Part A : AUCinf under fasting condition
大体时间:0(predose)~48 hours
|
Area Under Curve(infinit) of the dapagliflozin
|
0(predose)~48 hours
|
Part A : AUCinf under fasting condition
大体时间:0(predose)~48 hours
|
Area Under Curve(infinit) of the metformin
|
0(predose)~48 hours
|
Part A : Tmax under fasting condition
大体时间:0(predose)~48 hours
|
Time of maximum concentration of the dapagliflozin
|
0(predose)~48 hours
|
Part A : Tmax under fasting condition
大体时间:0(predose)~48 hours
|
Time of maximum concentration of the metformin
|
0(predose)~48 hours
|
Part A : t1/2 under fasting condition
大体时间:0(predose)~48 hours
|
Half life of the dapagliflozin
|
0(predose)~48 hours
|
Part A : t1/2 under fasting condition
大体时间:0(predose)~48 hours
|
Half life of the metformin
|
0(predose)~48 hours
|
Part B : AUCinf under fed condition
大体时间:0(predose)~48 hours
|
Area Under Curve(infinit) of the metformin
|
0(predose)~48 hours
|
Part B : Tmax under fed condition
大体时间:0(predose)~48 hours
|
Time of Maximum concentration of the metformin
|
0(predose)~48 hours
|
Part B : t1/2 under fed condition
大体时间:0(predose)~48 hours
|
Half life of the metformin
|
0(predose)~48 hours
|
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。
调查人员
- 首席研究员:Ji-Young Park, M.D, Ph.D、Korea University Anam Hospital / Seoul, Seongbuk-Gu, South Korea
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 (实际的)
2019年8月6日
初级完成 (实际的)
2019年8月30日
研究完成 (实际的)
2019年10月2日
研究注册日期
首次提交
2019年11月6日
首先提交符合 QC 标准的
2019年11月6日
首次发布 (实际的)
2019年11月7日
研究记录更新
最后更新发布 (实际的)
2019年11月7日
上次提交的符合 QC 标准的更新
2019年11月6日
最后验证
2019年11月1日
更多信息
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.