NCT02091388已完成1 期
A Randomized, Open-Label, Parallel-Group Study to Assess the Relative Bioavailability of LY03004 and Risperdal® Consta® at 25 mg Following Multiple Intramuscular Injections in Stable Patients With Schizophrenia or Schizoaffective Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 9
- 主要终点
- Cmax, Tmax, for Relative bioavailability of LY03004 compared to Risperdal® Consta®
研究概览
简要总结
This study is to assess the bioavailability of LY03004 compared to Risperdal Consta as well as the evaluate the safety and tolerability and preliminary efficacy of LY03004 with repeat injections
详细描述
- To assess the relative bioavailability of LY03004 compared to Risperdal® Consta® at 25 mg following multiple intramuscular injections at steady-state;
- To evaluate the safety and tolerability of LY03004 following repeated intramuscular injections
- To evaluate the preliminary efficacy of LY03004 following repeated intramuscular injections
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged 18 to 65 years old
- •Patients must have a DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder based on the Mini-International Neuropsychiatric Interview (MINI)
- •Patients must be clinically stable on antipsychotic medications other than risperidone or paliperidone or clozapine for at least 4 weeks prior to screening, based on clinical assessments AND a Positive and Negative Syndrome Scale (PANSS) total score less than or equal 70 at Screening Visit
- •Patients with a Body Mass Index in range of 18.0 to 35.0
- •Patients with an Informed Consent Form signed by the patient or legally authorized representative
排除标准
- •Patients with a mental disorders other than schizophrenia or schizoaffective disorder, according to the DSM-IV-TR
- •Patients who received oral risperidone or paliperidone or clozapine within 14 days prior to screening, or Risperdal® Consta® within 100 days prior to screening or paliperidone palmitate within 10 months prior to screening
- •Patients with neuroleptic malignant syndrome or physical fatigue associated with dehydration or malnutrition
- •Patients who pose a significant risk of a suicide attempt based on history, investigator's judgment or have answered "yes" to the questions 4 or 5 for current or past 30 days on the screening form of the Columbia Suicide Severity Rating Scale (C-SSRS)
- •Patients with a history of sensitivity to akathisia and other EPS, especially with previous use of risperidone or paliperidone
- •Patients with uncontrolled diabetes mellitus as indicated by a HbA1c level greater than or equal to 7%
- •Patients with a history of or currently having epilepsy or convulsion disorders
- •Patients who have had electroconvulsive therapy within the past 2 months prior to screening
- •Patients who used medication known to be an inducer or inhibitor for CYP 2D6 within 2 weeks prior to screening
- •Patients with a history of allergic reaction to risperidone or to the excipients of LY03004
- •Patients who have met DSM-IV-TR criteria for substance abuse or dependence with the exception of caffeine or nicotine in the past 6 months prior to screening
- •Patients with a history of clinically relevant cardiac arrhythmia's, cardiovascular disease, thyrotoxicosis, parkinsonism, or hemorrhagic diathesis
- •Patients who are currently taking medications with primarily CNS activities such as antidepressants, mood stabilizers or anticonvulsants
- •Patients who have participated in a clinical trial of another investigational drug within 30 days prior to screening
- •Female patients who are pregnant or are breastfeeding or are of childbearing potential without adequate use of contraception
- •Patients who have any clinically relevant hepatic, renal and cardiac dysfunction, or other medical condition or laboratory abnormality, which in the judgment of the investigator would interfere with the subject's ability to participate in the study
研究组 & 干预措施
LY03004 25 mg
Experimental
5 intramuscular injections 25 mg over 113 days
干预措施: LY03004 (Drug)
Risperdal® Consta® 25 mg
Active Comparator
5 intramuscular injections 25 mg over 113 days
干预措施: Risperdal® Consta® (Drug)
结局指标
主要结局
Cmax, Tmax, for Relative bioavailability of LY03004 compared to Risperdal® Consta®
时间窗: 113 Days
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(113 Days)
- The change of the PANSS score for the Preliminary efficacy of LY03004(113 Days)
研究者
研究点 (9)
Loading locations...
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