CTRI/2024/11/077367进行中（未招募）不适用
A multicenter, open-label, balanced, randomized, two-treatment, single-period, parallel-group, single-dose, bioequivalence study of Paliperidone palmitate 100 mg prolonged-release suspension for injection of Qilu Pharmaceuticals Co., Ltd. with Xeplion (paliperidone) 100 mg prolonged-release suspension for injection of Janssen-Cilag International NV in subjects with schizophrenia.
Qilu Pharmaceuticals Co., Ltd16 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2025年1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
- 240
- 试验地点
- 16
- 主要终点
- To assess the bioequivalence of Paliperidone palmitate 100 mg prolonged-release suspension for injection of Qilu Pharmaceuticals Co., Ltd. with Xeplion (Paliperidone) 100 mg prolonged-release suspension for injection of Janssen-Cilag International NV in subjects with schizophrenia.
研究概览
简要总结
A multicenter, open label, balanced, randomized, two-treatment, single-period, parallel-group, single-dose, bioequivalence study of Paliperidone palmitate 100 mg prolonged-release suspension for injection of Qilu Pharmaceuticals Co., Ltd. with Xeplion (paliperidone) 100 mg prolonged-release suspension for injection of Janssen-Cilag International NV in subjects with schizophrenia.
Primary Objective: To assess the bioequivalence of Paliperidone palmitate 100 mg prolonged-release suspension for injection of Qilu Pharmaceuticals Co., Ltd. with Xeplion (Paliperidone) 100 mg prolonged-release suspension for injection of Janssen-Cilag International NV in subjects with schizophrenia.
Secondary Objective: To monitor the adverse events and to ensure the safety of subjects.
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
- •Willing and able to provide written informed consent prior to any study related activities being performed and to follow the protocol requirements.
- •Male and female subjects aged 18-65 years (both inclusive) having body mass index between 18.50 to 30.00 kg per m2 (both inclusive).
- •Subjects diagnosed with schizophrenia as per DSM 5 TR criteria or later.
- •Schizophrenic subjects who are clinically stable, defined as no hospitalizations for acute exacerbations and who are stable on their current antipsychotic medications (apart from paliperidone and risperidone), for a duration of at least 3 months prior to screening.
- •NOTE- Subjects must NOT be taking greater than 2 antipsychotic medications for their disease.
- •Subjects who have tolerated oral or injectable paliperidone and/or risperidone prior to screening.
- •Acceptable hematology status a.
- •Hemoglobin greater than or equal to 9 g per dL b.
- •Absolute neutrophil count greater than or equal to 1500 cells per micro L c.
- •Platelet count greater than or equal to 100000 cells per micro L d.
- •WBC count greater than or equal to 4000 cells per micro L
- •Acceptable liver function a.
- •Bilirubin less than 1.5 X ULN d.
- •Alkaline phosphatase less than or equal to 2.5 X ULN
- •Subjects with creatinine clearance greater than or equal to 80 mL per minute (using the Cockcroft-Gault Equation).
- •Female subjects of childbearing potential with negative serum pregnancy test at screening and negative urine pregnancy test on Day
- •Female subjects of childbearing potential (defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during study participation) practicing two acceptable methods of contraception during the study.
- •Acceptable methods of contraception are a.
- •Oral, parenteral, patch, or implant hormonal contraception b.
- •Intrauterine device or intrauterine system c.
- •Double barrier method of contraception (condom and occlusive cap or condom and spermicidal agent) d.
- •Male sterilization (at least 6 months prior to screening, should be the sole male partner for that subject) e.
- •Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least 6 weeks prior to study participation f.
- •Total abstinence partial abstinence is not acceptable
- •No history of addiction to any recreational drug or drug dependence or alcohol addiction.
排除标准
- •Hypersensitivity to paliperidone palmitate or risperidone or to any of the excipients of the formulations.
- •Subjects with history of or a current DSM 5 TR diagnosis of concurrent mental disorder besides schizophrenia (eg.
- •schizoaffective-disorder, major depressive disorder, bipolar I disorder, bipolar II disorder, general anxiety disorder, obsessive-compulsive disorder, posttraumatic stress disorder, dementia or mild neurocognitive disorder, and personality disorder).
- •Subjects who have been administered a.
- •oral paliperidone or risperidone within 3 months prior to screening b.
- •injectable risperidone within 6 months prior to screening c.
- •injectable paliperidone 1-month formulation within 12 months prior to screening d.
- •Strong CYP3A4 inducer or P-gp inducers within 2 weeks prior to randomization (or within five half-lives since the last drug administration, whichever is greater), or is expected to require such treatment during the study.
- •Subjects with history of or have current thoughts of suicide (suicidal ideation) or violent tendencies at screening visit as per the Investigators discretion.
- •Subjects who are in an acutely agitated or severely psychotic state.
- •Subjects with congenital long QT syndrome or demonstration of repeated prolonged QTc interval greater than 470 msec in females and greater than 450 msec in males (QTc interval to be calculated with Bazetts Formula), as measured on more than one ECG (either during screening, or from prior medical record) or presence of severe cardiovascular disease defined as having required cardiovascular surgery or the occurrence of incapacitating myocardial infarction within 12 months prior to screening.
- •Presence of orthostatic hypotension (ie.
- •a drop in systolic blood pressure of 20 mmHg or more and/or a drop in diastolic blood pressure of 10 mmHg or more within 3 minutes of standing from supine or history of syncope at screening.
- •Subjects with history or presence of neuroleptic malignant syndrome (NMS), tardive dyskinesia, dementia-related psychosis, Parkinsons disease or epilepsy or seizures.
- •Subjects with history or presence of any uncontrolled systemic disease (e.g., cardiovascular disease, hypertension (systolic BP greater than or equal to 150 mmHg per diastolic BP greater than or equal to 100 mmHg), diabetes mellitus (HbA1c greater than or equal to 9% at the time of screening), etc.)
- •Subjects who need to remain on antipsychotic treatment(s) that are incompatible to co-treatment with paliperidone or risperidone or that may interfere or impede clinically with a single dose of paliperidone.
- •Subjects with history of arrhythmia, venous thromboembolism, Intraoperative floppy iris syndrome.
- •Subjects with positive urine screen for drugs of abuse (including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, and morphine, except for benzodiazepines, which is a permissible medication if supported by prescription).
- •Subjects with positive urine alcohol test.
- •Subjects with positive serology for Hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
- •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 that would limit adherence to study requirements.
- •Participation in any clinical study within 90 days before the Investigational Product administration.
- •Loss of greater than or equal to350 mL (1 unit) of blood within 90 days prior to administration of Investigational Product for the current study.
- •Lactating women.
结局指标
主要结局
To assess the bioequivalence of Paliperidone palmitate 100 mg prolonged-release suspension for injection of Qilu Pharmaceuticals Co., Ltd. with Xeplion (Paliperidone) 100 mg prolonged-release suspension for injection of Janssen-Cilag International NV in subjects with schizophrenia.
时间窗: Day 01(Pre Dose 00.00hrs),Day01,02,03,04,06,08,10,12, | 14,16,18,20,25,29,32,46,60,74,95,116,137,158 (Post Dose 06.00hrs, | 24.00hrs,48.00hrs,72.00hrs, 120.00hrs ,168.00hrs,216.00hrs,264.00hrs, | 312.00hrs,360.00hrs, 408.00hrs,456.00hrs,576.00hrs, ,672.00hrs, 744.00hrs, 1080hrs, 1416.00hrs, 1752.00hrs, 2256.00hrs, 2760.00hrs, 3264.00hrs, 3768.00hrs)
次要结局
- To monitor the adverse events & to ensure the safety of subjects.(Day 01(Pre Dose 00.00hrs),Day01,02,03,04,06,08,10,12,)
研究者
Dr Sandeep Singh
CBCC Global Research
研究点 (16)
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