An open label, multi-center, balanced, randomized, two-treatment, single-period, parallel group, multiple dose, steady state, bioequivalence study of Paliperidone Palmitate Prolonged Release Suspension for injection 100 mg of Qilu Pharmaceuticals Co., Ltd with Xeplion Prolonged Release suspension for Injection 100 mg of Janssen-Cilag International NV in subjects with schizophrenia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 16
- 主要终点
- To achieve bioequivalence between both test and reference product by both primary and secondary PK endpoints.
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, bioequivalence study of paliperidone palmitate Prolonged Release Suspension for injection 100 mg of Qilu Pharmaceuticals Co., Ltd with Xeplion Prolonged Release suspension for Injection 100 mg 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, no changes in any antipsychotic medication within 3 months.
- •Subjects who are already receiving a stable regimen of paliperidone palmitate prolonged release suspension 100mg via the intramuscular route and have completed at least 2 maintenance doses prior to randomization.
- •Note: For the subjects who will enter in to the lead-in period, the criteria will be evaluated during screening part II.
- •Acceptable hematology status: a.
- •Hemoglobin greater than or equal to 9 g per dL b.
- •Absolute neutrophil count (ANC) greater than or equal to 1500 cells per micro L c.
- •Platelet count greater than or equal to 100,000 cells per micro L d.
- •WBC count greater than or equal to 4000 cells per micro L
- •Acceptable liver function: a.
- •Alanine aminotransferase less than or equal to 2.5 X upper limit of normal b.
- •Aspartate aminotransferase (AST) less than or equal to 2.5 X ULN c.
- •Bilirubin less than 1.5 mg per dL 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 with negative serum pregnancy test at screening and negative urine pregnancy test before randomization.
- •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.
- •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.
- •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 with history of or have current thoughts of suicide (suicidal ideation) or violent tendencies at the time of screening as per the Investigators discretion.
- •Subjects with history or presence of neuroleptic malignant syndrome (NMS) or tardive dyskinesia.
- •Subjects with history or presence of Parkinsons disease or epilepsy or seizures.
- •Subjects who are in an acutely agitated or severely psychotic state.
- •Elderly subjects with dementia-related psychosis treated with antipsychotic drugs.
- •Demonstration of repeated prolonged QTc interval (Bazetts formula (QTcB)) greater than 450ms in males and greater than 470ms in females, 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.
- •Subjects with history of arrhythmia, venous thromboembolism, Intraoperative floppy iris syndrome.
- •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 positive urine alcohol test.
- •Subjects with positive urine screen for drugs of abuse (including benzodiazepine, amphetamine, barbiturates, cannabinoid, cocaine, and morphine, except for benzodiazepine, which is a permissible medication if supported by prescription)
- •History or presence of any uncontrolled systemic disease (eg.
- •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 percent at the time of screening), etc.
- •Subjects with positive serology for Hepatitis B surface antigen and hepatitis B core antibody, Hepatitis C Virus or Human Immunodeficiency Virus.
- •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 first Investigational Product administration.
- •Loss of greater than or equal to 350 mL (1 unit) of blood within 90 days prior to first dose of Investigational Product.
- •Lactating women.
结局指标
主要结局
To achieve bioequivalence between both test and reference product by both primary and secondary PK endpoints.
时间窗: Day 85,113,141(Pre Dose 00.00hrs),Day141,142,143,144,145,148, | 151,154,157,160,163,166,169(Post Dose 06.00hrs,24.00hrs,48.00hrs,72.00hrs, | 96.00hrs ,168.00hrs,240.00hrs,312.00hrs,384.00hrs,456.00hrs,528.00 hrs,600.00 hrs,672.00hrs)
The primary PK endpoint is to demonstrate bioequivalence for the
时间窗: Day 85,113,141(Pre Dose 00.00hrs),Day141,142,143,144,145,148, | 151,154,157,160,163,166,169(Post Dose 06.00hrs,24.00hrs,48.00hrs,72.00hrs, | 96.00hrs ,168.00hrs,240.00hrs,312.00hrs,384.00hrs,456.00hrs,528.00 hrs,600.00 hrs,672.00hrs)
following steady state PK parameters:
时间窗: Day 85,113,141(Pre Dose 00.00hrs),Day141,142,143,144,145,148, | 151,154,157,160,163,166,169(Post Dose 06.00hrs,24.00hrs,48.00hrs,72.00hrs, | 96.00hrs ,168.00hrs,240.00hrs,312.00hrs,384.00hrs,456.00hrs,528.00 hrs,600.00 hrs,672.00hrs)
Maximum plasma concentration at steady state.
时间窗: Day 85,113,141(Pre Dose 00.00hrs),Day141,142,143,144,145,148, | 151,154,157,160,163,166,169(Post Dose 06.00hrs,24.00hrs,48.00hrs,72.00hrs, | 96.00hrs ,168.00hrs,240.00hrs,312.00hrs,384.00hrs,456.00hrs,528.00 hrs,600.00 hrs,672.00hrs)
AUC during a dosage interval at steady state.
时间窗: Day 85,113,141(Pre Dose 00.00hrs),Day141,142,143,144,145,148, | 151,154,157,160,163,166,169(Post Dose 06.00hrs,24.00hrs,48.00hrs,72.00hrs, | 96.00hrs ,168.00hrs,240.00hrs,312.00hrs,384.00hrs,456.00hrs,528.00 hrs,600.00 hrs,672.00hrs)
Concentration at the end of the dosing interval at steady state.
时间窗: Day 85,113,141(Pre Dose 00.00hrs),Day141,142,143,144,145,148, | 151,154,157,160,163,166,169(Post Dose 06.00hrs,24.00hrs,48.00hrs,72.00hrs, | 96.00hrs ,168.00hrs,240.00hrs,312.00hrs,384.00hrs,456.00hrs,528.00 hrs,600.00 hrs,672.00hrs)
次要结局
- Average concentration during a dosing interval (Cavg,ss)(Time until Cmax,ss is reached (Tmax,ss).)
研究者
Dr Sandeep Singh
CBCC Global Research