CTRI/2018/08/015469已完成不适用
A Randomized, Multicenter, Multiple-dose, Two-treatment, Parallel, Steady State Bioequivalence Study of Paliperidone palmitate ER Injectable Suspension (546 mg; Mylan) and INVEGA TRINZA ER Injectable Suspension (546 mg; Janssen Pharmaceuticals, Inc) 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
- 264
- 试验地点
- 12
- 主要终点
- To demonstrate the bioequivalence of Mylan’s Paliperidone Palmitate
研究概览
简要总结
A bioequivalence study with Paliperidone in subjects with schizophrenia.
This study includes:
· Screening period:
Male and non-pregnant female subjects with schizophrenia will be eligible for the screening procedure. A written informed consent will be obtained prior to initiating screening procedures.
· Treatment period:
Subjects will be randomized to receive either Mylan’s Paliperidone Palmitate Extended-Release Injectable Suspension or Janssen’s INVEGA TRINZA® (Paliperidone Palmitate) extended-release injectable suspension as intramuscular injection as per randomization schedule (either the test or reference product) in a parallel design. Subject will be randomized in a 1:1ratio to Test or Reference product.
Main conclusion on the bioequivalence will be drawn based on the PK data obtained during last dosing interval.
Statistical analysis of pharmacokinetic parameters comparing test and reference products will be performed to assess bioequivalence.
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
- •1.Men or non-pregnant, non-lactating females aged 18-65 years (inclusive) having clinical diagnosis of schizophrenia.
- •2.Subjects with Body Mass Index (BMI) less than or equal to 35 but greater than or equal to 18 at screening and randomization.
- •3.Subjects who are already receiving a stable regimen of the 156 mg of monthly paliperidone palmitate extended release suspension or 546 mg of the three-month paliperidone palmitate extended release suspension via the intramuscular route prior to randomization.
- •4.Subjects with established tolerability to oral paliperidone/risperidone or injectable paliperidone prior to screening.
- •5.Subjects who are clinically stable and not hospitalized for exacerbation of psychiatric symptoms during 3 months before randomization.
- •6.Adequate hematological parameters at screening and randomization.
- •7.Adequate hepatic and renal function at screening and randomization.
- •8.Subject and LAR must demonstrate adequate decision-making ability to make a choice about participating in this study and provide written informed consent to participate.
- •Agree to comply with the visit schedule and other requirements of the study.
排除标准
- •1.History of known hypersensitivity to paliperidone, risperidone, or to any excipients in study medications. 2.Subjects with dementia related psychosis. 3.Subjects with a history of Neuroleptic Malignant Syndrome (NMS) while on treatment with antipsychotics. 4.History or presence of circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with use of drugs that prolong QTc interval 5.Presence of uncontrolled metabolic disorders. 6.Subjects with known cardiovascular disease. 7.Subjects with clinically significant hyperprolactinemia or with possible prolactin dependent tumor. 8.History of severe hepatic impairment or drug induced leukopenia/neutropenia/ agranulocytosis. 9.Subjects with Clinical Global Impression.
- •Severity of illness (CGIS) score of 5 or more. 10.Subjects with history or presence of tardive dyskinesia, seizures, idiopathic Parkinson’s disease, cognitive and motor impairment. 11.Subjects who are on active treatment with drugs that are known to interact with paliperidone. 12.Have a history of alcohol or drug-dependence as per DSM-V criteria during the 6-month period immediately prior to screening. 13.Subjects with clinically significant laboratory investigations as per the investigator’s judgment. 14.Attempted suicide within 12 months before screening or are at imminent risk of suicide or violent behavior as clinically assessed by the investigator. 15.Male or female of childbearing potential unwilling to use adequate methods of contraception throughout the study. 16.Subjects who had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery, or whom have surgery scheduled during the course of the study. 17.Subjects with known positivity for human immunodeficiency virus (HIV), HBsAg or HCV. 18.Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product in the study. 19.Any reason which, in the opinion of the Principal Investigator or Co-Investigator, would prevent the subject from safely participating in the study.
结局指标
主要结局
To demonstrate the bioequivalence of Mylan’s Paliperidone Palmitate
时间窗: Day 360
Extended-Release Injectable Suspension with Janssen’s INVEGA TRINZA in subjects with Schizophrenia
时间窗: Day 360
次要结局
- To evaluate the safety and tolerability of Mylan’s Paliperidone Palmitate Extended-Release Injectable Suspension in subjects with schizophrenia(Day 360)
研究者
研究点 (12)
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