Bioequivalence of ICI176,334-1 in Japanese Healthy Male Subjects
2012年5月29日 更新者：AstraZeneca
Bioequivalence Study of ICI176,334-1 in Japanese Healthy Male Subjects - Evaluation of Bioequivalence of ICI176,334-1 and Casodex 80 mg Tablet -
The purpose of this study is to investigate the bioequivalence of ICI176,334-1 in Japanese healthy male subjects.
研究概览
详细说明
Bioequivalence study of ICI176,334-1 in Japanese healthy male subjects - evaluation of bioequivalence of ICI176,334-1 and Casodex 80 mg tablet -
研究类型
介入性
注册 (实际的)
48
阶段
- 阶段1
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
20年 至 45年 (成人)
接受健康志愿者
是的
有资格学习的性别
男性
描述
Inclusion Criteria:
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Japanese healthy male subjects aged 20 to 45 years
- Male subjects should be willing to use barrier contraception ie, condoms, until 3 months after the last dose of investigational product
- Have a body mass index (BMI) between 17 and 27 kg/m2
- Eligible based on the physical findings, supine BP, pulse rate, ECG and laboratory assessments, as judged by the investigator(s)
Exclusion Criteria:
- Presence of any disease under medical treatment
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, immunological, blood, endocrine, neurological or mental disease to interfere with absorption, distribution, metabolism or excretion of drugs judged by investigator(s)
- Presence of any infectious disease, such as bacteria, virus and fungus
- Presence of allergic disorder, such as asthma, pollen disease or atopic dermatitis, and judged as necessary any medical treatment
- Any large surgical history of gastrointestinal tract such as gastric/intestinal resection or suturation
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 |
|---|---|
|
实验性的：Active 1
12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
|
受试者将接受单剂量的 ICI176,334-1
受试者将接受单剂量的 Casodex 80 毫克片剂
|
|
实验性的：Active 2
12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
|
受试者将接受单剂量的 ICI176,334-1
受试者将接受单剂量的 Casodex 80 毫克片剂
|
|
实验性的：Active 3
12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
|
受试者将接受单剂量的 ICI176,334-1
受试者将接受单剂量的 Casodex 80 毫克片剂
|
|
实验性的：Active 4
12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
|
受试者将接受单剂量的 ICI176,334-1
受试者将接受单剂量的 Casodex 80 毫克片剂
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
To investigate the bioequivalence of ICI176,334-1 by assessment of maximum plasma concentration (Cmax)
大体时间：Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
|
Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
|
|
To investigate the bioequivalence of ICI176,334-1 by assessment of time to Cmax (tmax)
大体时间：Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
|
Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
|
|
To investigate the bioequivalence of ICI176,334-1 by assessment of area under the plasma concentration curve (AUC)
大体时间：Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
|
Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
|
|
To investigate the bioequivalence of ICI176,334-1 by assessment of t1/2 of bicalutamide
大体时间：Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
|
Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
To assess the safety by assessment of adverse event
大体时间：Screening day up to 35 to 42 days (follow-up)
|
Screening day up to 35 to 42 days (follow-up)
|
|
To assess the safety by assessment of vital signs
大体时间：Collect prior to treatment and up to 35 to 42 days (follow-up) after the last dose.
|
Collect prior to treatment and up to 35 to 42 days (follow-up) after the last dose.
|
|
To assess the safety by assessment of electrocardiograms (ECGs)
大体时间：Collect prior to treatment and up to 35 to 42 days (follow-up) after the last dose.
|
Collect prior to treatment and up to 35 to 42 days (follow-up) after the last dose.
|
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
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
2011年8月1日
初级完成 (实际的)
2011年11月1日
研究完成 (实际的)
2011年12月1日
研究注册日期
首次提交
2011年8月11日
首先提交符合 QC 标准的
2011年8月11日
首次发布 (估计)
2011年8月12日
研究记录更新
最后更新发布 (估计)
2012年5月30日
上次提交的符合 QC 标准的更新
2012年5月29日
最后验证
2012年5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.
ICI176,334-1的临床试验
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Fudan UniversityThe First Affiliated Hospital of Anhui Medical University; Guangdong Provincial Hospital of... 和其他合作者撤销