CTRI/2018/12/016671已完成不适用
A Randomized, Multicenter, Multiple-dose, Crossover, Steady-state, Bioequivalence Study of Aripiprazole Extended Release Injectable Suspension and Abilify Maintena® in Subjects with Schizophrenia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 10
- 主要终点
- “Evaluation of bioequivalence of Mylan’s Aripiprazole Extended-Release Injectable Suspension 400 mg with Abilify Maintena® (Aripiprazole) 400 mg of Otsuka Pharmaceutical Co., Ltd., Japan, in subjects with schizophrenia.â€
研究概览
简要总结
A bioequivalence study with Aripiprazole long acting injection in subjects with schizophrenia with the following objectives.
To demonstrate the bioequivalence of Mylan’s Aripiprazole Extended-Release Injectable Suspension 400 mg with Abilify Maintena® (Aripiprazole) of Otsuka Pharmaceutical Co., Ltd., in subjects with schizophrenia.
To evaluate the safety and tolerability of Mylan’s Aripiprazole Extended Release Injectable Suspension in subjects with Schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects must fulfill all the following inclusion criteria to be eligible for participation in the study:
- •Male or non-pregnant, non-lactating female subjects between 18 and 65 years of age (inclusive).
- •Documented diagnosis of schizophrenia
- •Subjects who are clinically stable and have had no hospitalization for exacerbation of psychiatric symptoms.
- •Currently stable on a regimen consisting of Aripiprazole Extended-Release Injectable Suspension
- •Subjects with established tolerability to oral Aripiprazole prior to screening.
排除标准
- •Subjects must not be enrolled in the study if they meet any of the following criteria:
- •Known or suspected allergy or hypersensitivity to aripiprazole or other constituents of the formulation.
- •History of medically significant adverse events or intolerance with aripiprazole based on investigator’s discretion.
- •Subjects who are on active treatment with drugs that are known to interact with Aripiprazole
- •Subjects with history or at risk of venous thromboembolism as per investigator’s discretion.
- •Subjects with poor GFR on screening.
- •Subjects with Clinical Global Impression – Severity of illness (CGI-S) score of 5 or more.
- •Subjects with inadequate muscle mass to receive the intramuscular injection according to the investigator.
- •Subjects with a history of Neuroleptic Malignant Syndrome (NMS) or tardive dyskinesia while on treatment with atypical antipsychotics.
- •Subjects with dementia related psychosis.
- •Subjects with history or presence of seizures or other conditions that potentially lower the seizure threshold.
- •Presence of significant orthostatic hypotension
- •History of drug induced leukopenia/ neutropenia/ agranulocytosis.
- •Subjects with abnormal hematological parameters at screening and randomization
- •Subjects with abnormal liver function tests at screening and randomization
- •History of alcohol or substance abuse during the 6-month period immediately prior to screening.
- •Male or female of childbearing potential unwilling to use adequate methods of contraception throughout the study.
- •Donation of blood within 90 days prior to receiving the first dose of investigational medicinal product in the study.
- •Subject who had major surgery within 4 weeks prior to study entry, who have not recovered from prior major surgery, or who have surgery scheduled during the course of the study.
- •Subjects with known positivity for human immunodeficiency virus (HIV), HBsAg and/or HCV.
- •Subjects having any other clinically significant finding of the physical examination or laboratory value or any reason which, in the opinion of the investigator, would prevent the subject from safely participating in the study.
结局指标
主要结局
“Evaluation of bioequivalence of Mylan’s Aripiprazole Extended-Release Injectable Suspension 400 mg with Abilify Maintena® (Aripiprazole) 400 mg of Otsuka Pharmaceutical Co., Ltd., Japan, in subjects with schizophrenia.â€
时间窗: 540 Days
次要结局
- Safety assessment:(Safety assessments include measurement and monitoring of vital signs, physical examination, weight examination, injection site reaction assessment, evaluation of severity of illness by assessing Clinical Global Impression – Severity of illness (CGI-S) scale, adverse events assessment and clinical laboratory assessment.)
研究者
研究点 (10)
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