临床试验/CTRI/2025/09/094623

CTRI/2025/09/094623招募中不适用

An open label, multi-center, balanced, randomized, two-treatment, single-period, parallel group, multiple dose, steady state, pharmacokinetic bioequivalence (BE) study of Paliperidone Palmitate Extended-Release Injectable Suspension (every 3 months) 350 mg of Qilu Pharmaceutical Co., Ltd with TREVICTA (Paliperidone Palmitate) 350 mg prolonged release suspension for injection of Janssen-Cilag International NV in subjects with schizophrenia.

Qilu Pharmaceutical Co Ltd.15 个研究点分布在 1 个国家目标入组 240 人开始时间: 2026年4月30日最近更新: 2026年2月27日

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 240
试验地点: 15
主要终点: To compare and evaluate the bioavailability and to characterize the pharmacokinetic profiles of Paliperidone Palmitate Extended-Release Injectable Suspension (every 3 months) 350 mg of

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

An open label, multi-center, balanced, randomized, two-treatment, single-period, parallel group, multiple dose, steady state, pharmacokinetic bioequivalence (BE) study of Paliperidone Palmitate Extended-Release Injectable Suspension (every 3 months) 350 mg of Qilu Pharmaceutical Co., Ltd with TREVICTA (Paliperidone Palmitate) 350 mg prolonged release suspension for injection of Janssen-Cilag International NV in subjects with schizophrenia.

Primary objective: To compare and evaluate the bioavailability and to characterize the pharmacokinetic profiles of Paliperidone Palmitate Extended-Release Injectable Suspension (every 3 months) 350 mg of Qilu Pharmaceutical Co., Ltd with TREVICTA (Paliperidone Palmitate) 350 mg prolonged release suspension for injection of Janssen-Cilag International NV in subjects with schizophrenia.

Secondary objective: To assess the safety and tolerability of the study treatments

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: None

入排标准

年龄范围: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•The subjects will be considered eligible for the study based on the following criteria: 1.Willing and able to provide written informed consent prior to any study-related activities being performed and to follow the protocol requirements.
•2.Male and female subjects aged between eighteen to sixty five years (both inclusive) having Body Mass Index between eighteen point five zero to thirty point zero zero kilograms per meter square (both inclusive).
•3.Subjects diagnosed with schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders Fifth Edition or later.
•4.Schizophrenic subjects who are clinically stable, defined as no hospitalizations for acute exacerbations and no changes in any antipsychotic medication for at least three months prior to screening.
•5.Subjects who are non-smokers and non-tobacco users, meaning they have no past history of smoking and tobacco consumption for at least three months prior to screening.
•6.Subjects who have received paliperidone palmitate prolonged release suspension at a dose of one hundred milligrams via the intramuscular route and have completed at least four doses prior to randomization or Subjects who have received paliperidone palmitate prolonged release suspension at a dose of three hundred fifty milligrams via the intramuscular route and have completed at least two doses prior to randomization.
•Note: For the subjects who will enter into the Lead-in period, the criteria will be evaluated during Screening Part Two.
•7.Acceptable hematology status: a.
•Hemoglobin greater than or equal to nine grams per deciliter b.
•Absolute neutrophil count greater than or equal to fifteen hundred cells per microliter c.
•Platelet count greater than or equal to one hundred thousand cells per microliter d.
•White blood cell count greater than or equal to four thousand cells per microliter 8.Acceptable liver function: a.
•Alanine aminotransferase less than or equal to two point five times upper limit of normal b.
•Aspartate aminotransferase less than or equal to two point five times upper limit of normal c.
•Total bilirubin less than or equal to one point five milligrams per deciliter d.
•Alkaline phosphatase less than or equal to two point five times upper limit of normal 9.Subjects with creatinine clearance greater than or equal to eighty milliliters per minute, using the Cockcroft-Gault Equation mentioned in the study protocol.
•10.Female subjects with negative serum pregnancy test at screening and negative urine pregnancy test on Day One.
•11.Female subjects of childbearing potential (defined as women physiologically capable of becoming pregnant, unless they are using an effective method of contraception during study participation) must agree to use two highly effective and complementary methods of contraception during study participation.
•Acceptable methods of contraception are: a.
•Oral or other hormonal contraception (such as injection, patch or implant) which has been used continuously for at least one month prior to the first dose of study medication b.
•Intrauterine device or intrauterine system c.
•Double barrier method of contraception (such as condom and occlusive cap or condom and spermicidal agent) d.
•Male sterilization performed at least six months prior to screening, and the male partner should be the sole partner of the subject e.
•Female sterilization, including surgical bilateral oophorectomy or tubal ligation performed at least six weeks prior to study participation f.
•Total abstinence; partial abstinence is not considered acceptable 12.No history of addiction to any recreational drug, drug dependence, or alcohol addiction.

排除标准

•Subjects will be excluded from the study based on the following criteria:
•Hypersensitivity to paliperidone palmitate or risperidone or to any of the excipients.
•Subjects with history of or a current DSM Five TR or later diagnosis of a concurrent mental disorder besides schizophrenia.
•This includes schizoaffective disorder, major depressive disorder, bipolar one disorder, bipolar two disorder, general anxiety disorder, obsessive compulsive disorder, posttraumatic stress disorder, dementia or mild neurocognitive disorder, and personality disorder.
•Subjects with history or presence of neuroleptic malignant syndrome, tardive dyskinesia or extrapyramidal symptoms.
•Subjects with concomitant treatment using hepatic enzyme inhibitors including fluoxetine or paroxetine, P glycoprotein inducers, or medications known to interact with the study medication within two weeks prior to the first injection of study medication.
•Note: If the subject was on any of these drugs, a sufficient washout period of at least five half lives must have elapsed between the last dose of such drug and the first dose of study medication.
•Current or anticipated use of any prohibited medications during the study participation.
•Subjects who have attempted suicide within twelve months prior to screening, or who had suicidal ideation within two months prior to screening based on Columbia Suicide Severity Rating Scale, or who exhibit violent tendencies or behavior as clinically assessed by the investigator.
•Subjects with symptomatic hyperprolactinemia or a suspected prolactin dependent tumor at the screening visit which, as judged by the investigator, could pose a safety risk to the subject or interfere with the conduct of the trial.
•Subjects with history or presence of Parkinson’s disease, epilepsy or seizures.
•Elderly subjects with dementia-related psychosis treated with antipsychotic medications.
•Subjects diagnosed with rhabdomyolysis, as evidenced by myoglobinuria.
•Subjects with clinically significant uncontrolled dyslipidemia.
•Subjects with congenital long QTc interval using Fridericia formula, greater than four hundred fifty milliseconds in males and greater than four hundred seventy milliseconds in females, as measured on more than one ECG either during screening or from prior medical records.
•Also excluded are those with severe cardiovascular disease defined as having required cardiovascular surgery or having had an incapacitating myocardial infarction within twelve months prior to screening.
•Subjects who are on medications known to cause significant QT interval prolongation.
•Subjects with history or presence of arrhythmia, venous thromboembolism, or intraoperative floppy iris syndrome
•Subjects with significant orthostatic hypotension, defined as a drop in systolic blood pressure of twenty millimeters of mercury or more and or diastolic blood pressure of ten millimeters of mercury or more within three minutes of standing from supine, or history of syncope at screening.
•Subjects with current alcoholism or a history of alcoholism within the last six months prior to screening, alcoholic liver disease, or other chronic liver disease.
•Subjects with history or presence of any uncontrolled systemic disease, such as hypertension defined as systolic blood pressure greater than or equal to one hundred fifty millimeters of mercury or diastolic blood pressure greater than or equal to one hundred millimeters of mercury, or diabetes mellitus with HbA1c greater than or equal to nine percent at the time of screening.
•Subjects who have undergone a major surgical procedure, including periodontal surgery, within twenty eight days prior to the first dose of the investigational product.
•Any other medical condition or serious intercurrent illness that, in the opinion of the investigator, may make it undesirable for the subject to participate in the study.
•Use of grapefruit or grapefruit products, Seville oranges and their juice, or recreational drugs within seventy two hours prior to investigational product administration on Day One.
•Ingestion of any caffeine or xanthine containing food or beverages such as tea, coffee, chocolate or cola drinks, tobacco or tobacco containing products such as pan, pan masala, gutkha, beedi or cigarette within forty eight hours prior to investigational product administration on Day One.
•Subjects who have tested positive for urine alcohol test or urine screen for drugs of abuse at the time of screening or on Day One.
•Use of alcohol or alcoholic products within forty eight hours prior to investigational product administration on Day One.
•Participation in any clinical study and or receipt of any clinical study medication within ninety days prior to first investigational product administration.
•Loss of three hundred fifty milliliters or more of blood within ninety days prior to the first dose of investigational product.
•Female subjects who are breastfeeding or lactating.
•Subjects with positive serology for Hepatitis B surface antigen, Hepatitis B core antibody, Hepatitis C virus, or Human Immunodeficiency Virus.

结局指标

主要结局

To compare and evaluate the bioavailability and to characterize the pharmacokinetic profiles of Paliperidone Palmitate Extended-Release Injectable Suspension (every 3 months) 350 mg of

时间窗: Day 181, 271, (Pre Dose), Day 361, 362 (Pre Dose 00.00 Hrs, Post Dose - 04.00 Hrs, 08.00 Hrs, 12.00 Hrs, 24.00 Hrs), 363 (48.00hrs), 366 (120.00hrs), 373 (288.00hrs), 380 (456.00hrs), 384 (552.00hrs), 387(624.00hrs), 390 (696.00hrs), 393 (768.00hrs), 396 (840.00hrs), 403 (1008.00hrs), 410 (1176.00hrs), 417 (1344.00hrs), 424 (1512.00hrs), 431 (1680.00hrs), 441 (1920.00hrs), 451 (2160.00hrs)

Qilu Pharmaceutical Co., Ltd with TREVICTA (Paliperidone Palmitate) 350 mg prolonged release suspension for injection of Janssen-Cilag International NV in subjects with schizophrenia.

次要结局

To assess the safety & tolerability of the study treatments.(For each subject, a total of twenty-three (23) PK blood samples of 2.0 mL each will be collected in the study.)

研究者

发起方

Qilu Pharmaceutical Co Ltd.

申办方类型

Pharmaceutical industry-Global

责任方

Principal Investigator

主要研究者

Dr Sandeep Singh

CBCC Global Research

研究点 (15)

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