A multicenter, open label, balanced, randomized, two-treatment, two-period, two-sequence, two-way crossover, multiple dose, steady-state bioequivalence study of Risperidone Long-acting intramuscular injection of Qilu Pharmaceuticals Co. Ltd. with RISPERDAL CONSTA® (Risperidone) LONG-ACTING INJECTION of Janssen Pharmaceuticals, Inc. Titusville, NJ 08560 in patients with schizophrenia or bipolar I disorder.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- To establish bioequivalence between Risperidone Long-acting intramuscular injection 25 mg/vial of Qilu Pharmaceuticals Co. Ltd. and RISPERDAL CONSTA® (Risperidone) LONG-ACTING INJECTION 25 mg/vial of Janssen Pharmaceuticals, Inc. Titusville, NJ 08560
研究概览
简要总结
Thisstudy is A multicenter, open label, balanced, randomized, two-treatment,two-period, two-sequence, two-way crossover, multiple dose, steady-statebioequivalence study of Risperidone Long-acting intramuscular injection of QiluPharmaceuticals Co. Ltd. with RISPERDAL CONSTA® (Risperidone) LONG-ACTINGINJECTION of Janssen Pharmaceuticals, Inc. Titusville, NJ 08560 in patientswith schizophrenia or bipolar I disorder.
Primary Objective: To assess the steady-statebioequivalence of Risperidone Long-acting intramuscular injection of QiluPharmaceuticals Co. Ltd. with RISPERDAL CONSTA® (Risperidone) LONG-ACTINGINJECTION of Janssen Pharmaceuticals, Inc. Titusville, NJ 08560 in patientswith schizophrenia or bipolar I disorder who are already receiving a stableregimen of Risperidone long-acting injection via the intramuscular route.
Secondary Objective: To monitor the adverse eventsand to ensure the safety of Patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Willing and able to provide voluntary informed consent and to follow the protocol requirements.
- •2.Patient aged 18-65 years (both inclusive) having Body Mass Index (BMI) between 17.00 and 30.00 (both inclusive) calculated as weight in kg/height in m
- •3.Patients with diagnosis of Schizophrenia or Bipolar I Disorder as per DSM-IV-TR criteria or later.
- •4.Patients receiving Risperidone long-acting injection at a dose of 25mg/vial via the intramuscular route and have completed at least 2 doses prior to randomization.
- •5.Acceptable hematology status: a.Hemoglobin greater than or equal to 9 g/dL b.Absolute neutrophil count (ANC) greater than or equal to 1500 cells/µL c.Platelet count greater than or equal to 100,000 cells/µL 6.Acceptable liver function: a.Alanine aminotransferase (ALT) less than or equal to 2X upper limit of normal (ULN) b.Aspartate aminotransferase (AST) less than or equal to 2X ULN c.Bilirubin less than 1.2 mg/dL d.Alkaline phosphatase less than or equal to 2X ULN 7.Patients with Creatinine clearance greater than or equal to 60 mL/minute 8.Female patients with negative urine pregnancy test on admission day and serum pregnancy test at screening.
- •9.Females of child bearing potential must be willing to use adequate contraception (as defined below) throughout the study and continuing for at least 3 months after the last dose of the investigational product.
- •For this study, acceptable and effective methods of contraception for females include: a.Intrauterine device placed at least 3 months prior to the start of the study and remaining in place during the study period, b.Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide plus a male or female condom) or c.Absolute sexual abstinence (no sexual intercourse or genital contact with a male partner).
- •10.For male patients, one of the following must apply in order to avoid impregnating a female partner, from the first study dose and agree to follow throughout the study and for at least 3 months following the last dose of the study.
- •a.Absolute sexual abstinence (no sexual intercourse or genital contact with a female partner).
- •b.Use of barrier method with spermicide 11.No history of addiction to any recreational drug or drug dependence or alcohol addiction.
排除标准
- •1.Hypersensitivity to Risperidone or Paliperidone or to any of the excipients.
- •2.Have current thoughts of suicide (suicidal ideation) or violent tendencies at the time of screening.
- •3.History or presence of neuroleptic malignant syndrome (NMS), tardive dyskinesia, dementia-related psychosis, Parkinson’s disease or epilepsy/seizures.
- •4.Patients with positive urine screen for Drug of Abuse.
- •5.Patients who are on active treatment with drugs that are known to interact with risperidone (such as Strong CYP2D6 inhibitors, CYP3A4 enzyme inducers).
- •6.Smokers who smokes greater than or equal to 10 cigarettes or equivalent per day.
- •7.Patients on different antipsychotic treatment.
- •8.Major surgical procedure (including periodontal) within 28 days of first dose of Investigational Product.
- •9.Surgical or other non-healing wounds.
- •10.Patients with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
- •11.Uncontrolled diabetes mellitus.
- •12.An unusual or abnormal diet, for whatever reason planned e.g. religious fasting during the course of the study.
- •13.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.
- •14.Participation in any clinical study within 90 days before the first dose of Investigational Product.
- •15.Donation and/or loss of 350 mL (1 unit) of blood within 90 days prior to first dose of Investigational Product for the current study.
- •16.Patient is currently Pregnant or breastfeeding.
结局指标
主要结局
To establish bioequivalence between Risperidone Long-acting intramuscular injection 25 mg/vial of Qilu Pharmaceuticals Co. Ltd. and RISPERDAL CONSTA® (Risperidone) LONG-ACTING INJECTION 25 mg/vial of Janssen Pharmaceuticals, Inc. Titusville, NJ 08560
时间窗: The pre-dose blood sample (00.00) will be drawn within 10 minutes prior to the scheduled dosing time on day 1, 43, 57 and 71 in Period 01 and on day 113, 141 and 155 in Period 02. | Post-dose blood samples after investigational product administration on day 1 and 15: 24.00, 48.00, 72.00, 96.00, 144.00, 192.00, 240.00, 288.00 and 336.00 hours and on day 71, 113 and 155: 12.00, 24.00, 48.00, 72.00, 96.00, 144.00, 192.00, 240.00, 288.00 and 336.00 hours.
次要结局
- To monitor the adverse events and to assess safety of patients(NA)