JPRN-jRCT2080223873已完成1 期
A multi-center, open-label clinical pharmacology study for comparative investigation of the pharmacokinetics, tolerability, and safety of three types of brexpiprazole (OPC-34712) once-weekly (QW) formulation administered as single oral doses in patients with schizophrenia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
研究概览
简要总结
All 22 subjects in Cohort 1 received a single brexpiprazole 2 mg conventional tablet dose in Period 1 and 20 of 22 subjects received a single brexpiprazole 12 mg QW formulation tablet dose and were analyzed for safety and PK. Of the 22 enrolled subjects, 20 subjects completed the trial and 2 subjects discontinued from the trial in Period 1. Sponsor discussed to decide not to proceed to cohort 2 since enough data was aquired to choose foumulation from chort 1.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 64age old（—）
- 性别
- All
入选标准
- •1)Patients with a diagnosis of schizophrenia based on the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)
- •2)Patients capable of staying at the trial site from the day before investigational medicinal product (IMP) administration to the 8th day following IMP administration in both Period 1 and Period 2
- •3)Patients with a body mass index [BMI = body weight (kg)/height (m)2] of 18.5 or higher and lower than 35.0
- •4)Persons who provide written informed consent before commencement of any trial-related procedures and whom the investigator or subinvestigator judges to be capable of following all the conditions of this trial
排除标准
- •1)Patients with a diagnosis of a concurrent mental disorder besides schizophrenia (schizoaffective disorder, major depressive disorder, bipolar I disorder, bipolar II disorder, general anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, dementia or mild neurocognitive disorder, personality disorder, etc) based on the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) (However, this exclusion does not apply to caffeine- or tobacco-related disorders)
- •2)Patients who fail to meet the specified requisite washout periods for the prohibited concomitant drugs and foods before commencement of IMP administration, or patients who are anticipated to take any of these drugs or foods during the study period
- •3)Patients who have previously undergone gastrointestinal surgery that could affect pharmacokinetic evaluations
- •4)Patients who have received electro-convulsive therapy within 60 days before commencement of IMP administration
- •5)Patients with clinically problematic disorders of the nervous system, liver, kidneys, metabolic system, blood, immune system, cardiovascular system, lungs, or digestive system (However, such patients may be included if the condition is mild or well-controlled and is considered to not affect safety or pharmacokinetic evaluations.)
研究者
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