A multicenter, open label, randomized, balanced, two-treatment, two-period, two-sequence, multiple dose, steady state crossover bioequivalence study of Paliperidone Palmitate Extended Release Injectable Suspension 156 mg of Sun Pharmaceutical Industries Limited, India. with that of Invega Sustenna® (Paliperidone Palmitate) Extended Release Injectable Suspension 156 mg of Janssen Pharmaceuticals, Inc. in patients with schizophrenia and/ or schizoaffective disorder
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 8
- 主要终点
- Primary Parameters: Peak concentrations during the dosing interval at steady-state, Area under the plasma concentration-time curve from time zero to time tau over a dosing interval at steady state
研究概览
简要总结
A comparative bioequivalence study Paliperidone Palmitate Extended Release Injectable Suspension 156 mg of Sun Pharmaceutical Industries Limited, India. with that of Invega Sustenna® (Paliperidone Palmitate) Extended Release Injectable Suspension 156 mg of Janssen Pharmaceuticals, Inc. in patients with schizophrenia and/ or schizoaffective disorder. The study will be conducted at multiple investigator sites across India. Sufficient number of patients will be screened and enrolled in order to have 80 evaluable patients. Enrolment will continue until at least 80 patients complete both study periods. There is two periods in this study. Patients shall be randomized either test or reference for consecutive five dosing i.e. on day 1, day 29, day 57, day 85, day 113 (Period 01). Patients will then be switched over to the other treatment (period 02) based on randomization schedule for the next consecutive five doses i.e. on day 141, day 169, day 197, day 225 and day 253. Patient shall continue to receive the injection in the same anatomical location i.e. deltoid or gluteal muscle as per randomization for the entire duration of the study. Deltoid injections should be alternated between the two deltoid muscles†and “Gluteal injections should be alternated between the two gluteal muscles. Alternate muscle is recommended to avoid any haematoma or other injection site adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
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.Patients willing and able to provide voluntary written informed consent and to follow the protocol requirements.
- •2.Male or Female patients with negative serum pregnancy test at screening, between 18 and 65 years of age, both inclusive, and having Body mass index equal or more than 18.00 calculated as weight in kg/height in m2 and at least 50 kg weight for male patients and 48 kg for female patients.
- •3.Patients who meets diagnostic criteria for schizophrenia and/ or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V).
- •4.Patients who are clinically stable and not hospitalized for exacerbation of psychiatric symptoms during 3 months before screening and till randomization.
- •5.Patients receiving Paliperidone long-acting injection at a dose of 156 mg/mL via the intramuscular route and have completed at least two maintenance doses prior to randomization.
- •Note: Patients who will enter in to the lead-in period: The criteria will be evaluated during screening part-II.
- •6.Acceptable hematology status: a.Hemoglobin ≥ 9.0 g/dL b.Absolute neutrophil count (ANC) ≥ 1500 cells/µL c.Platelet count ≥ 1,00,000 cells/µL
- •Acceptable liver function: a.Alanine aminotransferase (ALT) ≤ 2.0 X upper limit of normal (ULN) b.Aspartate aminotransferase (AST) ≤ 2.0 X ULN c.Total bilirubin < 1.2 mg/dL d.Alkaline phosphatase ≤ 2.0 X ULN 8.Patients with creatinine clearance ≥ 80 mL/minute (using the Cockcroft-Gault Equation).
- •9.Females of childbearing potential must be willing to use adequate contraception (as defined below) from the first study dose and agree to follow throughout the study and for at least 6 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 6 months prior to the first study dose and agree to follow throughout the study, 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) OR Females who are surgically sterile OR Females who are post-menopausal for at least one year 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 6 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 No history of addiction to any recreational drug or drug dependence or alcohol addiction.
排除标准
- •1.Known hypersensitivity to paliperidone Palmitate or risperidone or to any of the excipients of investigational product or to any other similar class of drugs.
- •2.Patients having current thoughts of suicide (suicidal ideation) or violent tendencies at the time of screening as per investigators discretion.
- •3.Patients with history or presence of neuroleptic malignant syndrome or tardive dyskinesia, dementia related psychosis, Parkinsons disease or epilepsy or seizures or cognitive and motor impairment.
- •4.Patients with history of arrhythmia.
- •5.Patients with positive urine screen for drugs of abuse (except for benzodiazepine which is a permissible medication supported by written prescription).
- •6.Patient with positive alcohol breath test.
- •7.History or current signs and symptoms of severe, progressive, or uncontrolled pulmonary, cardiac, gastrointestinal, hepatic, renal, genitourinary, hematological, endocrine, immunologic, metabolic or neurological disease.
- •8.Corrected QT interval [Bazetts formula] more than 450 msec (male) or more 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 family member with sudden unexplained cardiac death.
- •10.Significant orthostatic hypotension (i.e. a drop in systolic blood pressure of 20 mm Hg or more and or a drop in diastolic blood pressure of 10 mm Hg or more within 3 minutes of standing) or history of syncope at screening.
- •11.Current or anticipated use of any of the prohibited medications during study participation.
- •12.Patient with skin abnormalities or irritations at the potential injection site (right or left deltoid or gluteal) as determined by the investigator.
- •13.Smokers who smokes greater than or equal to 10 cigarettes or equivalent per day.
- •14.Any clinically significant abnormal laboratory parameter or clinically significant organ abnormality found evaluated during screening evaluation.
- •15.Patients with any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study that would limit adherence to study requirements.
- •16.Lactating women.
- •17.Current surgical or other non-healing wounds or major surgical procedure (including periodontal) within 28 days of first study dose of IP.
- •18.Patients with positive serology for Hepatitis B Virus, Hepatitis C Virus or Human Immunodeficiency Virus.
- •19.Participation in any clinical study within 90 days before the first dose of Investigational Product.
- •20.Loss of more than equal to 350 mL of blood within 90 days before the first dose of Investigational Product.
结局指标
主要结局
Primary Parameters: Peak concentrations during the dosing interval at steady-state, Area under the plasma concentration-time curve from time zero to time tau over a dosing interval at steady state
时间窗: At the end of the study when all 80 patients have | completed the study
Secondary Parameters: Minimum or trough concentrations at steady-state, Time of the maximum measured plasma concentration at steady state, Degree of fluctuation (percentage), Average plasma concentration at steady state, Swing
时间窗: At the end of the study when all 80 patients have | completed the study
次要结局
- To monitor the adverse events and to ensure the safety of patients after investigational product administration(At the end of the study when all 80 patients have)