Bioequivalence Study of ICI176,334-1 in Japanese Healthy Male Subjects - Evaluation of Bioequivalence of ICI176,334-1 and Casodex 80 mg Tablet -
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 48
- 主要终点
- To investigate the bioequivalence of ICI176,334-1 by assessment of maximum plasma concentration (Cmax)
研究概览
简要总结
The purpose of this study is to investigate the bioequivalence of ICI176,334-1 in Japanese healthy male subjects.
详细描述
Bioequivalence study of ICI176,334-1 in Japanese healthy male subjects - evaluation of bioequivalence of ICI176,334-1 and Casodex 80 mg tablet -
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
干预措施: ICI176,334-1 (Drug)
Active 1
12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
干预措施: Casodex 80 mg tablet (Drug)
Active 2
12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
干预措施: ICI176,334-1 (Drug)
Active 2
12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
干预措施: Casodex 80 mg tablet (Drug)
Active 3
12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
干预措施: ICI176,334-1 (Drug)
Active 3
12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
干预措施: Casodex 80 mg tablet (Drug)
Active 4
12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
干预措施: ICI176,334-1 (Drug)
Active 4
12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
干预措施: Casodex 80 mg tablet (Drug)
结局指标
主要结局
To investigate the bioequivalence of ICI176,334-1 by assessment of maximum plasma concentration (Cmax)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
次要结局
- To assess the safety by assessment of adverse event(Screening day up to 35 to 42 days (follow-up))
- To assess the safety by assessment of vital signs(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)(Collect prior to treatment and up to 35 to 42 days (follow-up) after the last dose.)