Bioequivalence Study Between YHP2508B and YHR2602 in Healthy Subjects
An Open-label, Randomized, Fasting, Single-dose, Oral Administration, 2-sequence, 4-period, Replicate Crossover Study to Evaluate Bioequivalence Between YHP2508B and YHR2602 in Healthy Subjects
An open-label, randomized, fasting, single-dose, oral administration, 2-sequence, 4-period, replicate crossover study to evaluate bioequivalence between YHP2508B and YHR2602 in healthy subjects.
研究概览
详细说明
44 healthy subjects will be randomized to one of 2 groups in the same ration.
Subjects in group 1 will be administered "YHR2602" and "YHP2508B" by crossover design on periods 1 to 4.
Subjects in group 2 will be administered "YHP2508C" and "YHR2603" by crossover design on periods 1 to 4.
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名：Jungwook Lee, MS
- 电话号码：82-2-828-0504
- 邮箱：clinicaltrials@yuhan.co.kr
学习地点
-
-
-
Gimpo-si、韩国
- 招聘中
- Gimpo Woori Hospital
-
-
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:
- BMI 18-30 kg/m2
- Those without clinically significant congenital or chronic diseases
Exclusion Criteria:
- Those who have participated in a bioequivalence study or other clinical trials and have been administered investigational products within 6 months prior to the first administration
- Those who are judged ineligible to participate in the trial by the principal investigator
- Female volunteers who are pregnant, suspected to be pregnant or breathfeeding
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：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：A(RTRT)
22 subjects, Cross-over, Single dose YHR2602 on period 1 and 3, Single dose of YHP2508B on period 2 and 4. |
Test drug Comparator drug |
|
实验性的：B(TRTR)
22 subjects, Cross-over, Single dose YHP2508B on period 1 and 3, Single dose of YHR2602 on period 2 and 4. |
Test drug Comparator drug |
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 |
|---|---|---|
|
Area under the plasma drug concentration-time curve [AUCt]
大体时间：0-72 hours
|
Area under the plasma drug concentration-time curve [AUCt] of Amlodipine, Telmisartan & Chlorthalidone |
0-72 hours
|
|
Maximum plasma concentration [Cmax]
大体时间：0-72 hours
|
Maximum plasma concentration [Cmax] of Amlodipine, Telmisartan & Chlorthalidone |
0-72 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time of peak concentration [Tmax]
大体时间：0-72 hours
|
Time of peak concentration [Tmax] of Amlodipine, Telmisartan & Chlorthalidone |
0-72 hours
|
|
Terminal phase of half-life [t1/2]
大体时间：0-72 hours
|
Terminal phase of half-life [t1/2] of Amlodipine, Telmisartan & Chlorthalidone |
0-72 hours
|
|
Area under the plasma drug concentration -time curve from 0 to infinity [AUCinf]
大体时间：0-72 hours
|
Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] of Amlodipine, Telmisartan & Chlothalidone |
0-72 hours
|
|
Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf]
大体时间：0-72 hours
|
Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf] of Amlodipine, Telmisartan & Chlothalidone |
0-72 hours
|
合作者和调查者
调查人员
- 首席研究员：Hyeonsoo Park, MD、Gimpo Woori Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
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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