CTRI/2018/01/011465已完成不适用
A randomized, single dose, balanced, multicenter, three-treatment, single period, parallel group, comparative bioavailability study of Paliperidone Intramuscular Injection
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 5
- 主要终点
- To assess bioavailability of WCK9003 Paliperidone Intramuscular Injection of Wockhardt Ltd., India compared with INVEGA SUSTENNA® (paliperidone palmitate) extended-release injectable suspension of Janssen Pharmaceuticals, Inc. USA, in adult patient of Schizophrenia, stabilized with Paliperidone.
研究概览
简要总结
A randomized, single dose, balanced, multicenter, three-treatment, single period, parallel group, comparative bioavailability study of WCK9003 Paliperidone Intramuscular Injection of Wockhardt Ltd., India compared with INVEGA SUSTENNA® (paliperidone palmitate) extended-release injectable suspensionof Janssen Pharmaceuticals, Inc. USA, in adult patient of Schizophrenia, stabilized with Paliperidone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Written informed consent for participation in the study by the patient and patient’s legal acceptable representative (LAR).
- •Schizophrenic patients between 18.0 years and above.
- •Patients who are stabilized on Paliperidone extended release tablet 9mg once a day (atleast 8 consecutive doses before IP administration).
- •Patients have a documented clinical diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), as confirmed by the investigator.
- •Not having any significant diseases or clinical significant abnormal findings except schizophrenia during screening, medical history, physical examination, laboratory evaluation, which may prevent to administer Paliperidone or Resperidone.
- •Able to comply with study procedures in the opinion of the investigator.
排除标准
- •Current or relevant history of serious, severe or unstable psychiatric illness except schizophrenia.
- •History of neuroleptic malignant syndrome, tardive dyskinesia, or any malignancy.
- •Elderly patients with dementia-related psychosis treated with antipsychotic drugs 4) Patient on different antipsychotic treatment and unable to shift on Paliperidone oral therapy.
- •Have a DSM-IV diagnosis of alcohol or substance dependence, with the exception of nicotine or caffeine dependence.
- •Be involuntarily-hospitalized or plan to undergo surgery/procedures during the course of the study 7) Patient has taken the following prohibited medications: Strong CYP3A4/P-glycoprotein (P-gp) inducers (e.g., carbamazepine, rifampin, St John’s wort) barbiturates within 14 days prior to randomization.
- •Have current thoughts of suicide (suicidal ideation) or violent tendencies at the time of screening.
- •Patient with any condition which in the opinion of the investigator makes the patient unsuitable for inclusion.
- •Personal / family history of allergy or hypersensitivity to Paliperidone or risperidone or its congeners or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator would compromise the safety of the patient or the study.
- •Evidence of impairment of renal, hepatic, cardiac, lungs or gastrointestinal function.
结局指标
主要结局
To assess bioavailability of WCK9003 Paliperidone Intramuscular Injection of Wockhardt Ltd., India compared with INVEGA SUSTENNA® (paliperidone palmitate) extended-release injectable suspension of Janssen Pharmaceuticals, Inc. USA, in adult patient of Schizophrenia, stabilized with Paliperidone.
时间窗: Pre-dose: 00 hours | Post-dose sample on day: 02, 04, 06, 08, 09, 10, 11, 12, 13, 14, 15, 16, 18, 20, 24, 28.
次要结局
- To monitor adverse events and ensure safety of the patients.(Exploratory Analysis of pharmacokinetic parameters.)
研究者
研究点 (5)
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