An Open Label, Randomized, Multicenter, Multiple-dose, Two-treatment, Single-period, Parallel,Steady State Bioequivalence Study of Paliperidone Palmitate Extended-Release Injectable Suspension 156 mg of Mylan Laboratories Limited, India and INVEGA SUSTENNAÂ® (Paliperidone Palmitate)Extended-Release Injectable Suspension 156 mg of Janssen Pharmaceuticals, Inc. Titusville, NJ 08560 in Subjects with Schizophrenia under Fasting Condition. - NA

Mylan Laboratories Limited0 个研究点目标入组 267 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 1 期
状态: 已完成
发起方: Mylan Laboratories Limited
入组人数: 267

研究概览入排标准研究者记录与标识符相似试验

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

•Subjects who qualify for the study should meet the following inclusion criteria:
•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.
•3.Subjects who are clinically stable and no hospitalization for exacerbation of psychiatric symptoms during 3 months before screening and randomization.
•4.Subjects with adequate renal function defined as creatinine clearance (Cockcroft-Gault Equation,) more than or equal to 80 mL/min.
•5.Adequate hematological parameters at screening and randomization defined by:
•Total white blood cell count more than or equal to 4000/mm3
•ANC more than or equal to 1500/mm3
•Platelet count more than or equal to 100,000/mm3
•Hemoglobin more than or equal to 9.0 gm/dl
•6.Adequate hepatic function at screening and randomization as defined by:
•Bilirubin less than 1.5 X ULN
•AST & ALT less than 5 X ULN
•7.Agree to comply with the visit schedule and other requirements of the study.

排除标准

•Subjects must not be enrolled in the study if they meet any one of the following criteria:
•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 atypical 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 the use of drugs that prolong the QTc interval
•5.Subjects with known cardiovascular disease (e.g., heart failure, history of myocardial infarction or ischemia, conduction abnormalities), cerebrovascular disease, or conditions that predispose the subject to hypotension (e.g., dehydration, hypovolemia, and treatment with antihypertensive medications).
•6.Subjects with clinically significant hyperprolactinemia or with possible prolactin dependent tumor.
•7.History of severe hepatic impairment and drug induced leukopenia/ neutropenia/ agranulocytosis.
•8.Subjects with Clinical Global Impression - Severity of illness (CGI-S) score of 5 or more.
•9.Subjects with history or presence of tardive dyskinesia, seizures or other conditions that potentially lower the seizure threshold, idiopathic Parkinsonâ??s disease, cognitive and motor impairment.
•10.Subjects who are on active treatment with drugs that are known to interact with paliperidone.
•11.Have a history of alcohol or drug-dependence as per DSM-V criteria during the 6-month period immediately prior to screening.
•12.Subjects with clinically significant laboratory investigations as per the investigatorâ??s judgment.
•13.Attempted suicide within 12 months before screening or are at imminent risk of suicide or violent behaviour as clinically assessed by the investigator.
•14.Treatment with any of the following therapies:
•Injection of risperidone long acting injection within 6 weeks before screening.
•Electroconvulsive therapy within 3months prior to screening.
•Clozapine within 3 months before screening.
•Nonselective or irreversible monoamine oxidase inhibitor (MAOI) antidepressants within 30 days before screening.
•Other antidepressant agents, unless subject had been on a stable dose for at least 3 months before screening and plans on remaining on that same exact regimen for the entire duration of the study.
•Mood stabilizers, including lithium and all anticonvulsants, beta-blockers, and anti-parkinsonian medication. Unless subjects on a stable dose for at least 3 months before screening and expect to remain on that same exact regimen throughout the duration of the study.
•15.Subjects who are:
•Breast feeding
•Male or female of childbearing potential unwilling to use adequate methods of contraception throughout the study.
•Subjects whom 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.
•Subjects with known positivity for human immunodeficiency virus (HIV), HBsAg or HCV.
•16.Participation in any interventional clinical study within the past 90 days of randomization.
•17.History of difficulty with donating blood or difficulty in accessibility of veins.

研究者

发起方

Mylan Laboratories Limited

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