CTRI/2026/07/114124进行中（未招募）不适用
A Randomized, Open Label, Multicenter, Multiple Dose, Two-treatment, Two-period, Two-way, Crossover Steady State Bioequivalence Study Between PALIPERIDONE EVER FSP 156 mg/ml TAPI 1 ML of EVER Valinject GmbH, Austria and Xeplion 100 mg [156 mg Paliperidone Palmitate Equivalent to 100 mg Paliperidone] Prolonged Release Suspension for Injection of Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, Belgiumi Adult Participants with Schizophrenia. - NIL
EVER Valinject GmbH0 个研究点目标入组 142 人开始时间: 2026年9月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 142
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Participant will be eligible for inclusion in this study only if all of the following criteria apply:
- •Male or non-pregnant, non-lactating female participant between age of 18 and 65 years with body mass index [BMI] between 18.5 to 30 kg per m2 and at-least 50 kg weight for male Participant and 48 kg for female Participant.
- •Participant with documented diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders Fifth Edition [DSM-V] or latest version criteria [refer Appendix I].
- •Participants who are clinically stable and not hospitalized for exacerbation of psychiatric symptoms for 3 months before screening and till randomization.
- •Participants who are already receiving stable regimen of 156 mg of paliperidone palmitate prolonged release suspension via the intramuscular route [at least 3 doses] prior to randomization.
- •Participant with established tolerability to oral Paliperidone prior to screening [applicable for scenario 2].
- •Acceptable hematology status:
- •a. Total white blood cell count Greater Than or Equal to 4000 per mm3
- •b. Hemoglobin Greater Than or Equal to 9.0 g per dL
- •c. Absolute neutrophils count [ANC] Greater Than or Equal to 1500 cell per microL
- •d. Platelet Count Greater Than or Equal to 1,00,000 Cells per microL
- •Acceptable liver function:
- •a. Alanine aminotransferase [ALT] Less Than 5.0 Multiply by upper limit of normal [ULN]
- •b. Aspartate aminotransferase [AST] Less Than 5.0 Multiply by ULN
- •c. Total bilirubin Less Than 1.5 mg per dL
- •d. Alkaline phosphatase Less Than 5.0 Multiply by ULN
- •Participants with Creatinine clearance Greater Than or Equal to 80 mL per minute [calculated using the Cockcroft Gault equation Formula of creatinine clearance in that Crcl is Equal to [140 Age] x mass [Kilogram weight] Divided By 72 x SCr in [mg per dL] [if Female x 85 percentage]]
- •Non-smoker [i.e., having no past history of smoking for at least one year prior to screening].
- •Female participant must be post-menopausal [at least 1 year], or of child-bearing potential must follow acceptable forms of contraception throughout the study duration.
- •Male Participants must agree to use a barrier method of contraception for the duration of the study if sexually active with a female of childbearing potential. Method of contraception should remain same throughout the study.
- •Participants with no history of addiction to any recreational drug or drug dependence or alcohol addiction.
- •Participant and LAR must demonstrate adequate decision making ability to make an informed decision about participating in this study by providing a written informed consent.
- •Participant having good general health and free of any disease state or physical condition that might impair evaluation of Schizophrenia.
- •Participant with free of exposure to any unacceptable risk by study participation as per investigator opinion.
排除标准
- •Participant will not be eligible for inclusion in this study if any of the following criteria apply:
- •Known hypersensitivity to paliperidone palmitate or risperidone or to any of the excipients of IMP or to any other similar class of drugs.
- •Participant having current thoughts of suicide [suicidal ideation] or violent tendencies at the time of screening as per investigators discretion [Refer Appendix II].
- •Participants with Clinical Global Impression - Severity of illness [CGI-S] score of 5 or more.
- •Participant with history or presence of neuroleptic malignant syndrome [NMS] or tardive dyskinesia, dementia-related psychosis, Parkinsons disease or epilepsy or seizures or cognitive and motor impairment.
- •Participant with a history of arrhythmia.
- •Participant with positive urine screen for drugs of abuse [except for benzodiazepine which is a permissible medication supported by written prescription].
- •Participant with positive urine alcohol test.
- •Participant with history or current signs and symptoms of severe, progressive or uncontrolled pulmonary, cardiac, gastrointestinal, hepatic, renal, genitourinary, hematological, endocrine, immunologic, metabolic or neurological disease.
- •Participant with a corrected QT interval [Bazett s formula [QTcB]] Greater Than 450 msec [male] or Greater Than 470 msec [female] at screening or prior to administration of the first dose of IP, or with a known history of Torsades de Points, or any family member with sudden unexplained cardiac death [Refer Appendix III].
- •History of cardiac disease, which predispose to QT prolongation [sick sinus, complete AV block, CHF, ventricular tachycardia, hypokalemia or hypocalcemia] or history of taking drugs that prolong QT.
- •Presence of uncontrolled metabolic disorders including uncontrolled diabetes mellitus [HbA1c Greater Than or Equal to 8 Percentage]
- •Participant with significant orthostatic hypotension [i.e., a drop in systolic blood pressure of 30mmHg or more and or a drop in diastolic blood pressure of 20mmHg or more on standing], uncontrolled hypertension [systolic BP Greater Than 150 mmHg per diastolic BP Greater Than or Equal to 100 mmHg].
- •Participants with clinically significant hyperprolactinemia or with possible prolactin dependent tumor.
- •Current or anticipated use of any of the prohibited medications during study participation.
- •Participant with skin abnormalities or irritations at the potential injection site [right or left gluteal muscle] as determined by the investigator.
- •History of severe hepatic impairment and drug induced leukopenia or neutropenia or agranulocytosis.
- •Participant who had major surgery within 28 days prior to screening, who have not recovered from prior major surgery, or who have surgery scheduled during the course of the study.
- •Participant with known positivity for human immunodeficiency virus [HIV], HBsAg and or HCV.
- •Participation in any interventional clinical study within the past 90 days of screening.
- •Donation of blood [1 unit or 350 mL] within 90 days prior to screening.
- •Participant 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 Participant from safely participating in th
研究者
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