A Clinical Trial to Evaluate the Safety and Pharmacokinetics of AJU-C52H in Healthy Volunteers
2021年10月1日 更新者：AJU Pharm Co., Ltd.
An Open Label, Randomized, Single Dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate the Safety and Pharmacokinetics of AJU-C52H Compared to Coadministration of C52R1M With C52R2 in Healthy Adult Volunteers
To evaluate the safety and pharmacokinetic characteristics of AJU-C52H in healthy adults
研究概览
详细说明
This study is to assess the safety and pharmacokinetic characteristics between co-administration of C52R1M with C52R2 and administration of AJU-C52H.
This is an open-label, randomized, single-dose, 2x2 crossover study in healthy subjects to assess the bioequivalence after taking the study drugs.
研究类型
介入性
注册 (预期的)
60
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。
学习联系方式
- 姓名：Jaewoo Kim, M.D., Ph.D.
- 电话号码：+82-70-4665-9193
- 邮箱：m3116@newyjh.com
学习地点
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Republic Of South Korea
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Seoul、Republic Of South Korea、大韩民国
- 招聘中
- H+ Yangji Hospital
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接触：
- Jaewoo Kim
- 电话号码：+827046659193
- 邮箱：m3116@newyjh.com
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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 及以上 (成人、年长者)
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 volunteers aged ≥ 19-year-old
- Weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30 kg/m2
- Those who are eligible for adequate 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 chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
- Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests
- Those who agree to contraception during the participation of clinical trial
- Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial
Exclusion Criteria:
- Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug
- Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of clinical trial drug
- Those who donated whole blood and apheresis within 8 weeks or received transfusion within 4 weeks
- Those who has a history of gastrointestinal surgery
- Those who exceeding an alcohol and smoke consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, Beer 250mL, Wine 30 mL) Smoke: 20 cigarettes/day
- Those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, dihydropyridine sensitivity, angioedema
- Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
- Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests
- Women who are pregnant or who may be pregnant and breastfeed
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 |
|---|---|
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实验性的：Sequence A
Period 1: C52R1M(Valsartan/Amlodipine) and C52R2(Chlorthalidone), single dose Period 2: AJU-C52H(FDC tablet, Valsartan/Amlodipine/Chlorthalidone), single dose
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Single oral dose C52R1M(FDC, Valsartan/Amlodipine) 160/5 mg tablet and C52R2(Chlorthalidone) 25 mg tablet taken together
其他名称：
Single oral dose AJU-C52(Valsartan/Amlodipine/Chlorthalidone) 160/5/25 mg FDC tablet
其他名称：
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实验性的：Sequence B
Period 1: AJU-C52H(FDC tablet, Valsartan/Amlodipine/Chlorthalidone), single dose Period 2: C52R1M(Valsartan/Amlodipine) and C52R2(Chlorthalidone), single dose
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Single oral dose C52R1M(FDC, Valsartan/Amlodipine) 160/5 mg tablet and C52R2(Chlorthalidone) 25 mg tablet taken together
其他名称：
Single oral dose AJU-C52(Valsartan/Amlodipine/Chlorthalidone) 160/5/25 mg FDC tablet
其他名称：
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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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Cmax of AJU-C52
大体时间：Pre-dose (0 hour), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
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Cmax: Maximum plasma concentration of the drug
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Pre-dose (0 hour), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
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AUCt of AJU-C52
大体时间：Pre-dose (0 hour), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
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AUCt: Area under the concentration-time curve from time zero to time
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Pre-dose (0 hour), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
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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 (实际的)
2021年9月17日
初级完成 (预期的)
2022年4月30日
研究完成 (预期的)
2022年4月30日
研究注册日期
首次提交
2021年10月1日
首先提交符合 QC 标准的
2021年10月1日
首次发布 (实际的)
2021年10月14日
研究记录更新
最后更新发布 (实际的)
2021年10月14日
上次提交的符合 QC 标准的更新
2021年10月1日
最后验证
2021年10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.
C52R1M Tab. and C52R2 Tab.的临床试验
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Odense University HospitalRigshospitalet, Denmark; Danish Cancer Society; REHPA, The Danish Knowledge Centre for Rehabilitation...完全的
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