A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-386(2)
An Open Label, Randomized, Single Dose, 2-sequence, 4-period, Cross-over Clinical Trial to Evaluate the Pharmacokinetics and Tolerability of CKD-386 With Co-administration of D013, D326, and D337 in Healthy Adult Volunteers
研究概览
详细说明
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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Gwanak-gu
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Seoul、Gwanak-gu、大韩民国、08779
- H Plus Yangji 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:
- Healthy adult volunteers aged ≥ 19 years
- Weight ≥50kg (man) or 45kg (woman), with calculated body mass index (BMI) of 18 to 30 kg/m2
Those who meet the blood pressure criteria during screening tests:
- Systolic Blood Pressure: 90 to 139 mmHg
- Diastolic Blood Pressure: 60 to 89 mmHg
- Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
- Those who are eligible for clinical trials based on laboratory(hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
- Those who agree to contraception during the participation of clinical trial.
- Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.
Exclusion Criteria:
- Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
- Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month before the first administration of investigational products.
- Those who donated whole blood or apheresis within 2 months or 1 month respectfully, or received blood transfusion within a month.
- Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
Those who exceed an alcohol and cigarette consumption than below criteria
• Alcohol: Man_21 glasses/week, Woman_14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL)
• Smoking: 20 cigarettes/day
Patients with the following diseases
- Patients with hypersensitivity to the main constituents or components of the investigational drug
- Severe hepatic impairment, biliary atresia or cholestasis
- Patients with hereditary angioedema or with a history of angioedema in the treatment of ACE inhibitors or angiotensin II receptor antagonists
- Diabetes mellitus
- Patients with moderate to severe renal impairment [glomerular filtration rate (eGFR) <60 mL / min / 1.73m^2]
- Renal vascular hypertension patients
- Patients with active liver disease, including unexplained persistent serum transaminase elevations or elevated serum transaminase elevations greater than three times the normal upper limit
- Patients with myopathy or have a history of family or genetic history of myopathy
- Hypothyroidism
- If you have a history of muscle toxicity for other HMG-CoA converting enzymes or fibrate class drugs
- Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
- Those who are deemed insufficient to participate in this clinical study by investigators.
- Woman who are pregnant or breastfeeding.
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:Sequence 1
Period 1: D013, D326, D337- A single oral dose of 3 tablets under fasting condition Period 2: CKD-386- A single oral dose of 1 tablet under fasting condition Period 3: D013, D326, D337- A single oral dose of 3 tablets under fasting condition Period 4: CKD-386- A single oral dose of 1 tablet under fasting condition |
QD, 采购订单
QD, 采购订单
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实验性的:Sequence 2
Period 1: CKD-386- A single oral dose of 1 tablet under fasting condition Period 2: D013, D326, D337- A single oral dose of 3 tablets under fasting condition Period 3: CKD-386- A single oral dose of 1 tablet under fasting condition Period 4: D013, D326, D337- A single oral dose of 3 tablets under fasting condition |
QD, 采购订单
QD, 采购订单
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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 |
|---|---|---|
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拍卖 CKD-386
大体时间:给药前(0小时)、0.25、0.5、0.75、1、1.5、2、3、4、8、12、24、48、72小时
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AUCt:从时间零到时间的浓度-时间曲线下的面积
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给药前(0小时)、0.25、0.5、0.75、1、1.5、2、3、4、8、12、24、48、72小时
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CKD-386 的 Cmax
大体时间:给药前(0小时)、0.25、0.5、0.75、1、1.5、2、3、4、8、12、24、48、72小时
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药物的最大血浆浓度
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给药前(0小时)、0.25、0.5、0.75、1、1.5、2、3、4、8、12、24、48、72小时
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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CKD-386 的 AUCinf
大体时间:给药前(0小时)、0.25、0.5、0.75、1、1.5、2、3、4、8、12、24、48、72小时
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AUCinf:从零到∞的浓度-时间曲线下的面积
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给药前(0小时)、0.25、0.5、0.75、1、1.5、2、3、4、8、12、24、48、72小时
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CKD-386 的最高温度
大体时间:给药前(0小时)、0.25、0.5、0.75、1、1.5、2、3、4、8、12、24、48、72小时
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Tmax:达到最大血浆浓度的时间
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给药前(0小时)、0.25、0.5、0.75、1、1.5、2、3、4、8、12、24、48、72小时
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CKD-386 的 AUCt/AUCinf
大体时间:给药前(0小时)、0.25、0.5、0.75、1、1.5、2、3、4、8、12、24、48、72小时
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AUCt/AUCinf
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给药前(0小时)、0.25、0.5、0.75、1、1.5、2、3、4、8、12、24、48、72小时
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CKD-386的T1/2
大体时间:给药前(0小时)、0.25、0.5、0.75、1、1.5、2、3、4、8、12、24、48、72小时
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T1/2:终末消除半衰期
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给药前(0小时)、0.25、0.5、0.75、1、1.5、2、3、4、8、12、24、48、72小时
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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 (实际的)
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 (实际的)
研究记录更新
最后更新发布 (实际的)
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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