A Study in Normal Healthy People, Testing Different Versions of a Pill That Will be Used to Treat Rheumatoid Arthritis.
2009年10月10日 更新者：Pfizer
An Open-Label Two-Part Randomized, Crossover Study Of The Pharmacokinetics Of CE-224,535 Administered As Controlled And Immediate Release Formulations In Healthy Volunteers
The study will try, in 2 separate parts, each using 12 research subjects, to see how a new form of the pill CE 224,535 gets released into the bloodstream and whether that is affected by food.
In each part, subjects will switch among 4 treatment periods to take either different forms of the pill(s) or the same form either after fasting or eating a meal.
The second part will only happen depending on whether the sponsor believes it is needed and will use separate subject than the first part.
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
11
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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Connecticut
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New Haven、Connecticut、美国、06511
- Pfizer Investigational Site
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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
18年 至 55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:
- aged 18-55 and healthy
Exclusion Criteria:
- severe chronic or uncontrolled medical or psychiatric conditions, including drug abuse
- pregnant or wanting to become pregnant
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
- 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 |
|---|---|
|
实验性的：Part1; controlled release formulation 4; 250 mg
one 250 mg controlled release tablet, once in the morning, in fasted state
|
one 250mg tablet, once in the morning in fasted state
其他名称：
2x250 mg tablets, once in the morning, in fasted state
其他名称：
4x250mg tablets, once in the morning, in fasted state
其他名称：
2x250mg tab, once in the morning, after being fed a high fat meal
其他名称：
4x125 mg tabs, once in the morning, in the fasted state.
This arm will only occur as part of Part 2, if needed, pending results of Part 1.
其他名称：
4x125 mg IR once in the morning after being fed a high fat meal
其他名称：
|
|
实验性的：Part1; controlled release formulation 4; 500 mg
2x250 mg, once in the morning, in fasted state
|
one 250mg tablet, once in the morning in fasted state
其他名称：
2x250 mg tablets, once in the morning, in fasted state
其他名称：
4x250mg tablets, once in the morning, in fasted state
其他名称：
2x250mg tab, once in the morning, after being fed a high fat meal
其他名称：
4x125 mg tabs, once in the morning, in the fasted state.
This arm will only occur as part of Part 2, if needed, pending results of Part 1.
其他名称：
4x125 mg IR once in the morning after being fed a high fat meal
其他名称：
|
|
实验性的：Part 1; controlled release formula 4; 1000 mg
4x250 mg tabs, once in the morning, in fasted state
|
one 250mg tablet, once in the morning in fasted state
其他名称：
2x250 mg tablets, once in the morning, in fasted state
其他名称：
4x250mg tablets, once in the morning, in fasted state
其他名称：
2x250mg tab, once in the morning, after being fed a high fat meal
其他名称：
4x125 mg tabs, once in the morning, in the fasted state.
This arm will only occur as part of Part 2, if needed, pending results of Part 1.
其他名称：
4x125 mg IR once in the morning after being fed a high fat meal
其他名称：
|
|
实验性的：Part 1; controlled release formulation 4; 500 mg FED
2x250 mg, once in the morning , in fed state
|
one 250mg tablet, once in the morning in fasted state
其他名称：
2x250 mg tablets, once in the morning, in fasted state
其他名称：
4x250mg tablets, once in the morning, in fasted state
其他名称：
2x250mg tab, once in the morning, after being fed a high fat meal
其他名称：
4x125 mg tabs, once in the morning, in the fasted state.
This arm will only occur as part of Part 2, if needed, pending results of Part 1.
其他名称：
4x125 mg IR once in the morning after being fed a high fat meal
其他名称：
|
|
实验性的：Part 2; IR formulation 500mg
4x125 mg tab of current formulation , once in the morning in the fasted state.
This arm will occur as Part 2, only as needed, pending results of Part 1
|
one 250mg tablet, once in the morning in fasted state
其他名称：
2x250 mg tablets, once in the morning, in fasted state
其他名称：
4x250mg tablets, once in the morning, in fasted state
其他名称：
2x250mg tab, once in the morning, after being fed a high fat meal
其他名称：
4x125 mg tabs, once in the morning, in the fasted state.
This arm will only occur as part of Part 2, if needed, pending results of Part 1.
其他名称：
4x125 mg IR once in the morning after being fed a high fat meal
其他名称：
|
|
实验性的：Part 2; IR formulation, 500 mg FED
4x125 mg once in the morning in the fed state.
This arm will occur as part of Part 2,only as needed, pending results of Part 1.
|
one 250mg tablet, once in the morning in fasted state
其他名称：
2x250 mg tablets, once in the morning, in fasted state
其他名称：
4x250mg tablets, once in the morning, in fasted state
其他名称：
2x250mg tab, once in the morning, after being fed a high fat meal
其他名称：
4x125 mg tabs, once in the morning, in the fasted state.
This arm will only occur as part of Part 2, if needed, pending results of Part 1.
其他名称：
4x125 mg IR once in the morning after being fed a high fat meal
其他名称：
|
|
实验性的：Part 2; controlled release formulation 5;500 mg, FASTED
2x250 controlled release formulation 5 tabs once in the morning in the fasted state.
This arm will only occur as part of Part 2, pending results of Part 1.
|
2x250 mg controlled release formulation 5 tabs once in the morning in the fasted state
其他名称：
2x250 mg controlled release formulation 5 once in the morning after being fed a high fat meal
其他名称：
|
|
实验性的：Part 2; controlled release formulation 5;500 mg, FED
2x250 mg controlled release formulation 5 tabs once in the morning in the fed state.
This arm will only occur as part of Part 2 pending results of Part 1
|
2x250 mg controlled release formulation 5 tabs once in the morning in the fasted state
其他名称：
2x250 mg controlled release formulation 5 once in the morning after being fed a high fat meal
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
pharmacokinetic parameters: Tmax, Cmax, AUClast, AUC(0-00), C24, t1/2
大体时间：48 hrs
|
48 hrs
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
safety parameters including: renal and liver function, blood counts, electrolytes, ECG, and pregnancy testing
大体时间：48 hrs
|
48 hrs
|
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。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2009年1月1日
初级完成 (实际的)
2009年3月1日
研究完成 (实际的)
2009年3月1日
研究注册日期
首次提交
2009年2月2日
首先提交符合 QC 标准的
2009年2月5日
首次发布 (估计)
2009年2月6日
研究记录更新
最后更新发布 (估计)
2009年10月14日
上次提交的符合 QC 标准的更新
2009年10月10日
最后验证
2009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.
CE-224,535的临床试验
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National Taiwan University Hospital未知
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University Hospital, GrenobleCommissariat A L'energie Atomique招聘中