Interventional, Randomized, Single Dose, Open-label, Crossover, Bioequivalence Study in Healthy Men and Women to Compare Two Pharmaceutical Formulations of Flupentixol/Melitracen (Deanxit®) - in Fasted and Fed Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- AUC0-72h: flupentixol
研究概览
简要总结
The purpose of this study is to establish bioequivalence of flupentixol/meltracen, between a new film-coated tablet formulation and the marketed coated tablet formulation (Deanxit®), administered single dose in fasted and fed condition
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 ≤ 28 kg/m
- •Women must be non-pregnant and non-lactating
排除标准
- 未提供
研究组 & 干预措施
Cohort A1 Fasted condition
Subjects in cohort A1 will be administered the Investigational Medicinal Product in a fasted state, 30 subjects per cohort
干预措施: test treatment: flupentixol/melitracen (Drug)
Cohort A1 Fasted condition
Subjects in cohort A1 will be administered the Investigational Medicinal Product in a fasted state, 30 subjects per cohort
干预措施: reference treatment: flupentixol/melitracen (Drug)
Cohort A2 Fed condition
Subjects in cohort A2 will be administered the Investigational Medicinal Product in a fed state, 30 subjects per cohort
干预措施: test treatment: flupentixol/melitracen (Drug)
Cohort A2 Fed condition
Subjects in cohort A2 will be administered the Investigational Medicinal Product in a fed state, 30 subjects per cohort
干预措施: reference treatment: flupentixol/melitracen (Drug)
结局指标
主要结局
AUC0-72h: flupentixol
时间窗: from zero to 72 hours post-dose
the area under the flupentixol plasma concentration-time curve
AUC0-72h: melitracen
时间窗: from zero to 72 hours post-dose
the area under the melitracen plasma concentration-time curve
Cmax: melitracen
时间窗: from zero to 72 hours post-dose
maximum observed concentration of melitracen
Cmax: flupentixol
时间窗: from zero to 72 hours post-dose
maximum observed plasma concentration of flupentixol
次要结局
未报告次要终点