CTRI/2018/08/015469已完成未知
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. - Nil
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 264
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
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 Parkinsonâ??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 investigatorâ??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.
研究者
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