Evaluation of Pharmacokinetics and Safety of AJU-A51 in Healthy Adults
2021年7月20日 更新者:AJU Pharm Co., Ltd.
A Randomized, Open, Single-dose, 2x2 Crossover Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Co-administration of A51R1 and A51R2 or Administration of AJU-A51 in Healthy Volunteers Under Fasting Conditions
To evaluate the safety and pharmacokinetic characteristics of AJU-A51 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 A51R1 with A51R2 and administration of AJU-A51.
This is an open-label, randomized, single-dose, 2x2 crossover study in healthy male and female subjects to assess the bioequivalence after taking the study drugs.
研究类型
介入性
注册 (实际的)
48
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
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Korea
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Daejeon、Korea、大韩民国
- Jang Hee Hong
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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
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Healthy adults over the age of 19 years at the time of screening
Individuals who had 18.5 kg/m2 ≤ Body Mass Index(BMI) < 29.9 kg/m2 and total body weight ≥ 50 kg
* BMI = Weight(kg)/ Height(m)2
- Individuals who were deemed to be appropriate as study subjects screening examination(laboratory tests and ECG etc.)
- Individuals who agreed proper contraception during the study
- Individuals who signed an informed consent form and decided to participate in the study after being fully informed of the study prior to participation
Exclusion Criteria:
- Individuals with a medical evidence or a history of clinically significant hepatobiliary, renal, neurologic, respiratory, digestive, endocrine, blood-oncology, urinary, cardiovascular, musculoskeletal or psychiatric
- Individuals with an active chronic or acute disease within 1 month.
- Individuals with a medical history of gastrointestinal disease (e.g., Crohn's disease and ulcer) or gastrectomy (excluding simple appendectomy or herniotomy) that may affect drug absorption
- Individuals with a severe allergies(except for allergic rhinitis or dermatitis)
Individuals with the following medical histories at screening test:
- T1DM or diabetic ketoacidosis
- Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
- Renal disorder or pancreatitis etc.
- A history of regular alcohol consumption exceeding 21 units/week within the 3 months(1 unit = 10 g = 12.5 ml) prior to screening or individuals who cannot quit drinking from 48hr prior to the first
- Individuals who cannot eat standard meal in institution
- Women who are pregnant or may be pregnant
- Individuals who were deemed to be inappropriate to participate in the study by the investigator
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: AJU-A51R1 tablet(Dapagliflozin) and AJU-A51R2 tablet(Linagliptin), single dose Period 2: AJU-A51(FDC tablet, Linagliptin/Dapagliflozin), single dose
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Single oral dose AJU-A51(Dapagliflozin/Linagliptin) 10 mg / 5 mg FDC tablet
其他名称:
Single oral dose A51R1(Dapagliflozin) 10 mg tablet and A51R2(Linagliptin) 5 mg tablet taken together
其他名称:
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实验性的:Sequence B
Period 1: AJU-A51(FDC tablet, Linagliptin/Dapagliflozin), single dose Period 2: AJU-A51R1 tablet(Dapagliflozin) and AJU-A51R2 tablet(Linagliptin), single dose
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Single oral dose AJU-A51(Dapagliflozin/Linagliptin) 10 mg / 5 mg FDC tablet
其他名称:
Single oral dose A51R1(Dapagliflozin) 10 mg tablet and A51R2(Linagliptin) 5 mg tablet taken together
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 |
---|---|---|
AUCt(Area Under Curve last) of AJU-A51
大体时间:predose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72hours post-dose
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Area under the plasma concentration time curve of AJU-A51
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predose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72hours post-dose
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Cmax
大体时间:predose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72hours post-dose
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The maximum concentration observed of AJU-A51 over blood sampling time.
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predose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72hours post-dose
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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。
调查人员
- 首席研究员:Jang Hee Hong、Chungnam National University
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)
2020年8月1日
初级完成 (实际的)
2020年11月30日
研究完成 (实际的)
2021年3月9日
研究注册日期
首次提交
2021年7月12日
首先提交符合 QC 标准的
2021年7月20日
首次发布 (实际的)
2021年7月22日
研究记录更新
最后更新发布 (实际的)
2021年7月22日
上次提交的符合 QC 标准的更新
2021年7月20日
最后验证
2021年7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.
AJU-A51 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