Interventional, Single Dose, Open-label, Randomised, Crossover, Bioequivalence Study in Healthy Men and Women to Compare Two Pharmaceutical Formulations of Flupentixol/Melitracen (Deanxit®)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Area under the flupentixol plasma concentration-time curve from zero to 72 hours post dose (AUC0-72h)
研究概览
简要总结
To establish bioequivalence of flupentixol/melitracen between a new film-coated tablet formulation of 0.5 mg flupentixol/10 mg melitracen and the marketed coated tablet formulation of 0.5 mg flupentixol/10 mg melitracen (Deanxit®), administered as single doses.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women ≥18 and ≤55 years of age with a body mass index (BMI) of >18.5 and <30 kg/m
- •Women will be non-pregnant and non-lactating.
- •Other protocol-defined inclusion and exclusion criteria may apply.
排除标准
- 未提供
研究组 & 干预措施
Flupentixol/melitracen film-coated tablet
test treatment - 0.5 mg/10 mg; oral as a single dose
干预措施: Flupentixol/melitracen film-coated tablet (Drug)
Flupentixol/melitracen coated tablet (Deanxit®)
reference treatment - 0.5 mg/10 mg, oral as a single dose
干预措施: Flupentixol/melitracen coated tablet (Deanxit®) (Drug)
结局指标
主要结局
Area under the flupentixol plasma concentration-time curve from zero to 72 hours post dose (AUC0-72h)
时间窗: Up to 72 hours post dose
Maximum observed concentration (Cmax) of flupentixol
时间窗: Up to 312 hours post dose
Area under the melitracen plasma concentration-time curve from zero to 72 hours post dose (AUC0-72h)
时间窗: Up to 72 hours post dose
Maximum observed concentration (Cmax) of melitracen
时间窗: Up to 312 hours post dose
次要结局
未报告次要终点