A Randomised, Open Label, Single Centre, 2 Way Crossover Bioequivalence Study Comparing Arimidex Tablet 1 mg and Anastrozole Orally Rapid Disintegration Film Formula 1 mg After Single Oral Administration in Japanese Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Investigation whether anastrozole ODF is bioequivalent with Arimidex tablet.
研究概览
简要总结
This study is to investigate whether anastrozole ODF is bioequivalent with Arimidex tablet after a single oral administration of each anastrozole formulation.
详细描述
A Randomised, Open label, Single centre, 2 way Crossover Bioequivalence Study Comparing Arimidex Tablet 1 mg and Anastrozole Orally Rapid Disintegration Film Formula 1 mg After Single Oral Administration in Japanese Healthy Male Subjects
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 18 and 27 kg/m2
排除标准
- •History of any clinically significant disease or disorder
- •History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs Any clinically significant illness, medical/surgical procedure or trauma
- •Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results
研究组 & 干预措施
1
2 way crossover
干预措施: Anastrozole ODF (Drug)
2
2 way crossover
干预措施: Arimidex tablet (Drug)
3
2 way crossover
干预措施: Anastrozole ODF (Drug)
4
2 way crossover
干预措施: Arimidex tablet (Drug)
结局指标
主要结局
Investigation whether anastrozole ODF is bioequivalent with Arimidex tablet.
时间窗: Blood samples are taken repeatedly for 24 hours and also taken occasionally up to 168 hours after each dose
By assessment of AUC and Cmax of anastrozole after a single oral administration of each anastrozole formulation.
次要结局
- Evaluation of the pharmacokinetic properties of Arimidex tablet and anastrozole ODF following a single oral dose.(Blood samples are taken repeatedly for 24 hours and also taken occasionally up to 168 hours after each dose)
- Evaluation of the safety and tolerability of Anastrozole ODF 1 mg.(Safety variables are measured prior to treatment and up to 14 to 17 days (follow-up) after the last dose. Subjects will be monitored throughout the study for adverse events)