Evaluation of Pharmacokinetics and Safety of Aripiprazole IM Depot Formulation by Single Administration in Chinese Patients With Schizophrenia: a Single-center, Uncontrolled, Open -Label Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Apparent clearance after extravascular administration
研究概览
简要总结
This study assess pharmacokinetics and safety of single-administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg in patients with schizophrenia.
详细描述
In this study, a single-center, single-dose, single-administration trial will be carried out in patients with schizophrenia diagnosed pursuant to The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR), to evaluate pharmacokinetics and safety of single-administration aripiprazole IM Depot (300/400 mg) after its administration in 24 patients with oral tolerance of this drug.
In this study, the washout period before administration is designed as a 35-day duration before administration of the investigational drug (aripiprazoleIM Depot), screening period a 4-week duration (28 days) before administration of the investigational drug, observation period after administration a 20-week duration after administration of the investigational drug and hospital stay a minimum 35-day duration after administration of the investigational drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Patients who have other psychiatric disorders than schizophrenia based on diagnostic criteria of DSM-IV-TR;
- •Score of Positive and Negative Syndrome Scale (PANSS): ≥120;
- •Patients with a complication or a history of diabetic mellitus;
- •Subjects who are alcoholemia overdependent of drug, or have drug abuse history;
- •Other protocol-defined inclusion and exclusion criteria may apply.
研究组 & 干预措施
Abilify IM Depot 300mg by once
300 mg dose group: single-administration of Aripiprazole IM Depot (300 mg) in 12 subjects;
干预措施: Aripiprazole IM Depot (Drug)
Abilify IM Depot 400mg by once
400 mg dose group: single-administration of Aripiprazole IM Depot (400 mg) in 12 subjects.
干预措施: Aripiprazole IM Depot (Drug)
结局指标
主要结局
Apparent clearance after extravascular administration
时间窗: up to 20 weeks
To assess the Apparent clearance after extravascular administration (CL/F) of aripiprazole
AUC0-∞
时间窗: up to 20 weeks
To assess the area under the curve for period of medication, from 0 till infinity (AUC0-∞) of aripiprazole and its main metabolite OPC-14857
Maximum Plasma Concentration
时间窗: up to 20 weeks
To assess the maximum Plasma Concentration (Cmax) of aripiprazole and its main metabolite OPC-14857
Time of Maximum Concentration
时间窗: up to 20 weeks
To assess the time of Maximum Concentration (tmax) of aripiprazole and its main metabolite OPC-14857
次要结局
- Adverse Events(up to 20 weeks)
- Laboratory Examination(up to 20 weeks)
- Vital Signs(up to 20 weeks)