Interventional, Open-label, Randomised, Crossover, Comparative Study of the Pharmacokinetics and Bioequivalence of Two Flupentixol Formulations - Film Coated Tablet (Test Treatment) - 0.5 mg, 1 mg and 5 mg (H. Lundbeck A/S, Denmark) and Coated Tablet (Fluanxol®) - 0.5 mg, 1 mg and 5 mg (H. Lundbeck A/S, Denmark) in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- The area under the plasma concentration-time curve
研究概览
简要总结
To establish bioequivalence between new film-coated tablet formulations of 0.5 mg, 1 mg and 5 mg flupentixol and the marketed coated tablet formulations of 0.5 mg, 1 mg, and 5 mg flupentixol, administered as single doses
详细描述
All subjects will be confined to the clinic from Day -1 (Baseline) until Day 6 (120 hours post-dose) for each dosing period. First and second dosing will be separated by a washout period of at least 21 days
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
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •body mass index (BMI) of ≥18.5 and ≤30 kg/m2
- •The subject is, in the opinion of the investigator, generally healthy based on medical history, physical examination, vital signs, electrocardiogram (ECG), and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests.
排除标准
- •The subject is pregnant or breastfeeding.
- •The subject has taken any investigational medicinal products 3 months prior to the first dose
- •The subject has tested positive at the Screening Visit or at the Baseline Visit for drugs of abuse (opiates, methadone, cocaine, amphetamines [including ecstasy], barbiturates, benzodiazepines, and cannabinoids).
- •Other protocol defined inclusion and exclusion criteria may apply
研究组 & 干预措施
0.5 mg reference, then 0.5 mg Test
14 Subjects will receive a 0.5 mg single dose of two different pharmaceutical formulations (first reference, then test)
干预措施: 0.5 mg Flupentixol film-coated tablet (test treatment) (Drug)
0.5 mg Test, then 0.5 mg reference
14 Subjects will receive a 0.5 mg single dose of two different pharmaceutical formulations (first test, then reference)
干预措施: 0.5 mg Flupentixol film-coated tablet (test treatment) (Drug)
0.5 mg Test, then 0.5 mg reference
14 Subjects will receive a 0.5 mg single dose of two different pharmaceutical formulations (first test, then reference)
干预措施: 0.5 mg Flupentixol coated tablet (reference treatment) (Drug)
0.5 mg reference, then 0.5 mg Test
14 Subjects will receive a 0.5 mg single dose of two different pharmaceutical formulations (first reference, then test)
干预措施: 0.5 mg Flupentixol coated tablet (reference treatment) (Drug)
1 mg Test, then 1 mg reference
14 Subjects will receive a 1 mg single dose of two different pharmaceutical formulations (first test, then reference)
干预措施: 1 mg Flupentixol film-coated tablet (test treatment) (Drug)
1 mg Test, then 1 mg reference
14 Subjects will receive a 1 mg single dose of two different pharmaceutical formulations (first test, then reference)
干预措施: 1 mg Flupentixol coated tablet (reference treatment) (Drug)
1 mg reference, then 1 mg Test
14 Subjects will receive a 1 mg single dose of two different pharmaceutical formulations (first reference, then test)
干预措施: 1 mg Flupentixol film-coated tablet (test treatment) (Drug)
1 mg reference, then 1 mg Test
14 Subjects will receive a 1 mg single dose of two different pharmaceutical formulations (first reference, then test)
干预措施: 1 mg Flupentixol coated tablet (reference treatment) (Drug)
5 mg Test, then 5 mg reference
14 Subjects will receive a 5 mg single dose of two different pharmaceutical formulations (first test, then reference)
干预措施: 5 mg Flupentixol film-coated tablet (test treatment) (Drug)
5 mg Test, then 5 mg reference
14 Subjects will receive a 5 mg single dose of two different pharmaceutical formulations (first test, then reference)
干预措施: 5 mg Flupentixol coated tablet (reference treatment) (Drug)
5 mg reference, then 5 mg Test
14 Subjects will receive a 5 mg single dose of two different pharmaceutical formulations (first reference, then test)
干预措施: 5 mg Flupentixol film-coated tablet (test treatment) (Drug)
5 mg reference, then 5 mg Test
14 Subjects will receive a 5 mg single dose of two different pharmaceutical formulations (first reference, then test)
干预措施: 5 mg Flupentixol coated tablet (reference treatment) (Drug)
结局指标
主要结局
The area under the plasma concentration-time curve
时间窗: from 0 to 72 hours post-dose
The maximum observed concentration (Cmax)
时间窗: from 0 to 72 hours post-dose
次要结局
未报告次要终点