NCT01415791已完成1 期
Oral Mucosal Absorption of ICI176,334-1 in Japanese Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 8
- 主要终点
- To investigate the presence or absence of oral mucosal absorption of ICI176,334-1 by assessment of concentration of bicalutamide in plasma
研究概览
简要总结
The purpose of this study is to investigate the presence or absence of oral mucosal absorption of ICI176,334-1
详细描述
Oral mucosal absorption of ICI176,334-1 in Japanese healthy male subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Active 1
Experimental
8 subjects will receive ICI176,334-1
干预措施: ICI176,334-1 (Drug)
结局指标
主要结局
To investigate the presence or absence of oral mucosal absorption of ICI176,334-1 by assessment of concentration of bicalutamide in plasma
时间窗: Samples are 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 saliva
时间窗: Samples are taken at 168 hours after application of the investigational drug
次要结局
- To assess the safety by assessment of adverse event(Adverse Events will be captured starting from screening up to 14 to 21 days (follow-up))
- To evaluate the safety by evaluation of vital signs(Collect prior to treatment and up to 14 to 21 days (follow-up) after application of the investigational drug)
- To evaluate the safety by assessment of electrocardiograms (ECGs)(Collect prior to treatment and up to 14 to 21 days (follow-up) after application of the investigational drug)
研究者
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