A Single-Dose Study to Evaluate the Pharmacokinetic, Safety, Tolerability Profile and the Effects of Food on the Pharmacokinetics of Different Formulations of Cariprazine in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- C[max]
研究概览
简要总结
The investigators are doing this study to compare blood levels and side effects of cariprazine when it's taken as one of two 'slow release' tablets, or as an 'immediate release' capsule. The investigators will also find out if food affects the absorption of cariprazine into the bloodstream after a 'slow release' tablet.
详细描述
Comparison of blood levels and side effects of cariprazine when it's taken as one of two 'slow release' tablets, or as an 'immediate release' capsule. We'll also find out if food affects the absorption of cariprazine into the bloodstream after a 'slow release' tablet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Caucasian males aged 18-55 years with body mass index (BMI) ≥ 18 kg/m2 and ≤ 30 kg/m2
- •Have a semisupine pulse rate ≥ 40 bpm and ≤ 100 bpm during the vital sign assessment at screening and on admission (Day 1)
- •Agree to use an effective method of contraception and not have their partners become pregnant throughout the study and for up to 4 months after the administration of the IMP, or have been sterilized for at least 1 year
排除标准
- 未提供
研究组 & 干预措施
Cariprazine PR tablet B
Cariprazine prolonged release tablet B - fed
干预措施: Cariprazine PR tablet B (Drug)
Cariprazine PR tablet A
Cariprazine prolonged release tablet A - fed
干预措施: Cariprazine PR tablet A (Drug)
Cariprazine capsule
Cariprazine capsule - fasted
干预措施: Cariprazine capsule (Drug)
Cariprazine prolonged release tablet B
Cariprazine prolonged release tablet B - fasted
干预措施: Cariprazine prolonged release tablet B (Drug)
Cariprazine prolonged release tablet A
Cariprazine prolonged release tablet A - fasted
干预措施: Cariprazine prolonged release tablet A (Drug)
结局指标
主要结局
C[max]
时间窗: 0-672 hours
Maximum Serum Concentration of the parent drug
AUC
时间窗: 0-672 hours
Area Under the Serum Concentration-Time Curve of the parent drug
T[max]
时间窗: 0-672 hours
Time to Reach the Maximum Serum Concentration of the parent drug
次要结局
- Other PK parameters of the parent drug(0-672 hours)
- PK parameters of the metabolites, if applicable(0-672 hours)