Bioequivalence Study of ICI176,334-1 (Bicalutamide New Formulation) in Japanese Healthy Male Subjects - Evaluation of Bioequivalence of ICI176,334-1 and Casodex Tablet (80mg)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 102
- 主要终点
- To investigate the bioequivalence of ICI176,334-1 by assessment of Cmax (Maximum Concentration of drug).
研究概览
简要总结
The purpose of this study is to investigate the bioequivalence of Bicalutamide new formation with Casodex commercial tablet (80mg) in Japanese healthy male subjects
详细描述
Bioequivalence study of ICI176,334-1 (Bicalutamide new formulation) in Japanese healthy male subjects - evaluation of bioequivalence of ICI176,334-1 and Casodex tablet (80mg)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
34 subjects will receive ICI176,334-1without water
干预措施: ICI176,334-1 (Drug)
Active 2
34 subjects will receive ICI176,334-1 with water
干预措施: ICI176,334-1 (Drug)
Active 3
34 subjects will receive 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 Cmax (Maximum Concentration of drug).
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 AUC (concentration Area Under the Curve).
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 (half time) 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.(Subjects will be monitored for adverse events prior to treatment and up to 42 -49 days (follow-up) after the last dose.)
- To assess the safety by assessment of vital signs.(Subjects will be monitored for vital signs prior to treatment and up to 42 -49 days (follow-up) after the last dose.)
- To assess the safety by assessment of electrocardiograms (ECGs)(Subjects will be monitored for electrocardiograms(ECGs) prior to treatment and up to 42 -49 days (follow-up) after the last dose.)