Oral Mucosal Absorption Study of Bicalutamide New Formulation
2011年8月12日 更新者：AstraZeneca
Oral Mucosal Absorption Study of ICI176,334-1 (Bicalutamide New Formulation) in Japanese Healthy Male Subjects
The purpose of this study is to investigate the presence or absence of oral mucosal absorption of bicalutamide after ICI176,334.1 is given to Japanese healthy male subjects
研究概览
详细说明
Oral mucosal absorption study of ICI176,334-1 (Bicalutamide new formulation) in Japanese healthy male subjects
研究类型
介入性
注册 (实际的)
8
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：非随机化
- 介入模型：单组作业
- 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
8 subjects will receive ICI176,334-1
|
受试者将接受单剂量的 ICI176,334-1
|
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 presence or absence of oral mucosal absorption of ICI176,334-1 by assessment of concentration of bicalutamide in saliva.
大体时间：Blood samples are taken repeatedly for 72 hours and also taken at 168 hours after application of the investigational drug.
|
Blood samples are taken repeatedly for 72 hours and also taken at 168 hours after application of the investigational drug.
|
|
To investigate the presence or absence of oral mucosal absorption of ICI176,334-1 by assessment of concentration of bicalutamide in plasma.
大体时间：Blood samples are taken repeatedly for 72 hours and also taken at 168 hours after application of the investigational drug.
|
Blood samples are taken repeatedly for 72 hours and also taken at 168 hours after application of the investigational drug.
|
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：Subjects will be monitored for adverse events prior to treatment and up to 14 to 21 days (follow-up) after application of the investigational drug.
|
Subjects will be monitored for adverse events prior to treatment and up to 14 to 21 days (follow-up) after application of the investigational drug.
|
|
To assess the safety by assessment of vital signs.
大体时间：Subjects will be monitored for vital signs prior to treatment and up to 14 to 21 days (follow-up) after application of the investigational drug.
|
Subjects will be monitored for vital signs prior to treatment and up to 14 to 21 days (follow-up) after application of the investigational drug.
|
|
To assess the safety by assessment of electrocardiograms (ECGs).
大体时间：Subjects will be monitored for electrocardiograms (ECGs) prior to treatment and up to 14 to 21 days (follow-up) after application of the investigational drug.
|
Subjects will be monitored for electrocardiograms (ECGs) prior to treatment and up to 14 to 21 days (follow-up) after application of the investigational drug.
|
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
2010年7月1日
初级完成 (实际的)
2010年8月1日
研究完成 (实际的)
2010年8月1日
研究注册日期
首次提交
2011年8月12日
首先提交符合 QC 标准的
2011年8月12日
首次发布 (估计)
2011年8月15日
研究记录更新
最后更新发布 (估计)
2011年8月15日
上次提交的符合 QC 标准的更新
2011年8月12日
最后验证
2011年8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.