A Single-center, Uncontrolled, Open-label Clinical Trial Evaluating the Pharmacokinetic Characteristics and Safety of Aripiprazole IM Depot in Chinese Patients With Schizophrenia After Multi-dose Administration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax)
研究概览
简要总结
This study assess pharmacokinetics and safety of multi-administration of Aripiprazole IM Depot formulation at doses of 400mg in patients with schizophrenia.
详细描述
To evaluate the pharmacokinetics and safety of aripiprazole prolonged IM depot 400mg administered to Chinese adult subjects with schizophrenia every four weeks for 20 consecutive weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects, and their legal representatives(or their guardian ), who have signed the informed consent form(ICF);
- •Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR (295.30, 295.10, 295.20,295.90 , 295.60);
- •subjects, both male and female, who are at age between 18 and 64 (also including 18 and 64 years of age) at time of informed consent.
排除标准
- •Presence of other mental disorders than schizophrenia confirmed through diagnostic criteria of DSM-IV-TR;
- •Subjects who are alcoholomania or independent of drug, or have drug abuse history;
- •Positive for any of HIV antibody, HBsAg, HCV antibody and syphilis serology testing;
- •Other protocol-defined inclusion and exclusion criteria may apply.
研究组 & 干预措施
400 mg group
Aripiprazole IM depot 400mg will be administered every four weeks for 20 weeks after drug switch / steady dose of oral aripiprazole tablets (each subject will receive 5 intramuscular injections totally).
干预措施: Aripiprazole IM Depot (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax)
时间窗: up to 24 weeks
To assess the Maximum Plasma Concentration (Cmax) of aripiprazole and its primary metabolite OPC-14857 after administration of the fifth IMD dose.
AUC672h
时间窗: up to 24 weeks
To assess the time of maximum observed plasma concentration (tmax) of aripiprazole and its primary metabolite OPC-14857 after administration of the fifth IMD dose.
Apparent clearance after extravascular administration
时间窗: up to 24 weeks
To assess the apparent clearance after extravascular administration (CL/F) of aripiprazole after administration of the fifth IMD dose.
time of maximum observed plasma concentration (tmax)
时间窗: up to 24 week
To assess the time of maximum observed plasma concentration (tmax) of aripiprazole and its primary metabolite OPC-14857 after administration of the fifth IMD dose.
次要结局
- Adverse Events(up to 24 weeks)
- Vital Signs(up to 24 weeks)
- Laboratory Examination(up to 24 weeks)