Interventional, Randomised, Double-blind 4-way Crossover Study Comparing the Gastro-intestinal Tolerability and Absorption Profile of Vortioxetine After Administration of Modified-release Formulations and Immediate-release Formulation in Healthy Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Maximum observed concentration (Cmax) of vortioxetine
研究概览
简要总结
The purpose of this study is to evaluate the gastro-intestinal tolerability (nausea, vomiting, diarrhoea, abdominal discomfort, and abdominal pain) of vortioxetine following single oral doses of three modified-release (MR) capsules with differently coated multiple particles compared to one immediate-release (IR) tablet.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women ≥18 and ≤45 years of age with a body mass index (BMI) of >18.5 and <30.0 kg/m
- •Women will be of child-bearing potential with a confirmed non-pregnant and non-lactating status.
- •Other protocol-defined Inclusion and Exclusion Criteria may apply.
排除标准
- 未提供
研究组 & 干预措施
Encapsulated vortioxetine IR tablet, 20 mg
Single oral dose
干预措施: Encapsulated vortioxetine IR tablet, 20 mg (Drug)
Vortioxetine MR capsule 20 mg (pH 5.5)
Single oral dose
干预措施: Vortioxetine MR capsule 20 mg (pH 5.5) (Drug)
Vortioxetine MR capsule 20 mg (pH 6.0)
Single oral dose
干预措施: Vortioxetine MR capsule 20 mg (pH 6.0) (Drug)
Vortioxetine MR capsule 20 mg (pH 7.0)
Single oral dose
干预措施: Vortioxetine MR capsule 20 mg (pH 7.0) (Drug)
结局指标
主要结局
Maximum observed concentration (Cmax) of vortioxetine
时间窗: Up to 72 hours postdose
Frequency, severity and duration of reported gastro-intestinal tolerability (nausea, vomiting, diarrhoea, abdominal discomfort and abdominal pain)
时间窗: Up to 72 hours post-dose in each treatment period
Area under the vortioxetine plasma concentration-time curve from zero to 72 hours post-dose (AUC0-72h)
时间窗: Up to 72 hours postdose
Nominal time corresponding to the occurrence of Cmax (tmax)
时间窗: Up to 72 hours postdose
Gastro-intestinal tolerability (nausea) measured with 11-point Numerical Rating Scale
时间窗: Up to 24 hours post-dose in each treatment period
Gastro-intestinal tolerability (abdominal pain) measured with 11-point Numerical Rating Scale
时间窗: Up to 24 hours post-dose in each treatment period
Gastro-intestinal tolerability (abdominal discomfort) measured with 11-point Numerical Rating Scale
时间窗: Up to 24 hours post-dose in each treatment period
次要结局
未报告次要终点