A multicenter, randomized, open label, two treatment, two period, two sequence, multiple-dose, two-way, crossover, steady-state bioequivalence study of Paliperidone Palmitate 156 mg/ml Injectable Suspension of Amneal Pharmaceuticals Company GmbH, with INVEGA® SUSTENNA® (paliperidone palmitate) extended-release injectable suspension 156 mg/ml Manufactured for Janssen Pharmaceuticals, Inc. Titusville, NJ 08560, USA in schizophrenia patients
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 120
- 试验地点
- 12
- 主要终点
- To characterize the pharmacokinetic profile of the Test product – Paliperidone Palmitate 156 mg/ml Injectable Suspension of Amneal Pharmaceuticals Company GmbH, compared to INVEGA® SUSTENNA® (paliperidone palmitate) extended-release injectable suspension 156 mg/ml Manufactured for Janssen Pharmaceuticals, Inc.
研究概览
简要总结
This study is A multicenter,randomized, open label, two treatment, two period, two sequence, multiple-dose,two-way, crossover, steady-state bioequivalence study of Paliperidone Palmitate156 mg/ml Injectable Suspension of Amneal Pharmaceuticals Company GmbH, withINVEGA® SUSTENNA® (paliperidone palmitate) extended-release injectablesuspension 156 mg/ml Manufactured for Janssen Pharmaceuticals, Inc. Titusville,NJ 08560, USA in schizophrenia patients.
PrimaryObjective: To characterize the pharmacokinetic profile of the Test product –Paliperidone Palmitate 156 mg/ml Injectable Suspension of AmnealPharmaceuticals Company GmbH, compared to INVEGA® SUSTENNA® (paliperidonepalmitate) extended-release injectable suspension 156 mg/ml Manufactured forJanssen Pharmaceuticals, Inc. Titusville, NJ 08560, USA in schizophreniapatients who are already receiving a stable regimen of paliperidone palmitateextended release suspension intramuscularly and to assess their bioequivalence.
SecondaryObjective: To monitor the safety and tolerability of Paliperidone Palmitate 156mg/ml Injectable Suspension in schizophrenia patients who are already receivinga stable regimen of paliperidone palmitate extended release suspension via the intramuscularroute.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block 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
- •Men and women, 18 years of age or older with a body mass index of 18.50-30.00 kg/m2 at screening (both inclusive).
- •Ability to provide informed consent prior to participation in the study.
- •Women of childbearing potential (except for those who have completed one year since menopause or have gone through hysterectomy or bilateral tubal ligation within past 6 months) must have a negative pregnancy test at prior to enrolment in the study and must agree to use an adequate method of contraception during the study period.
- •Patients with schizophrenia and who are already receiving a stable regimen of Paliperidone palmitate extended release suspension via the intramuscular route.
- •No history of addiction to any recreational drug or drug dependence.
- •No participation in any clinical study within the past 60 days.
- •Clinically acceptable ECG in the opinion of an Investigator.
排除标准
- •A history of allergic or adverse reactions to Paliperidone palmitate or risperidone or any comparable or similar product.
- •A history of severe hepatic impairment, drug induced leukopenia/neutropenia.
- •Elderly patients with dementia-related psychosis.
- •Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, idiopathic Parkinson’s disease, epilepsy or risk for seizures, neuropsychiatric infection, neuroleptic malignant syndrome or disease.
- •A total white blood cell count below 3000/cmm and an absolute neutrophil count below 1500/cmm.
- •History or presence of circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval, including: bradycardia, clinically significant abnormality on the ECG, demonstration of repeated prolonged QTc (> 450 ms for male and > 470 ms for female patient), cardiac arrhythmias, myocardial infarction or unstable heart disease.
- •Are unable to stabilize on antipsychotic medication tapering during the study.
- •History of significant orthostatic hypotension, syncopal episodes and known case of cardiovascular or cerebro vascular disease and patients predispose to 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 on standing).
- •A medical or surgical condition that might interfere with the absorption, metabolism, or excretion of Paliperidone.
- •Expected changes in concomitant medications during the period of study.
- •Have a history of alcohol or drug-dependence during the 6-month period immediately prior to Screening.
- •Positive test results for urine drug scan or breath alcohol test at baseline.
- •Patients who are: Pregnant Breast feeding Male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the study Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from any prior major surgery Patients with known positivity for human immunodeficiency virus (HIV), HBsAg or HCV Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent
- •Subjects taking medications that irreversibly inhibit platelet function or anticoagulants.
- •Subject with metabolic disorders (uncontrolled diabetes mellitus and lipid abnormalities), clinically significant Hyperprolactinemia, cognitive and motor Impairment.
- •History of difficulty with donating blood or difficulty in accessibility of veins.
- •Donation of blood (1 unit or 360 ml) within 90 days prior to receiving the first dose of investigational medicinal product in the study.
结局指标
主要结局
To characterize the pharmacokinetic profile of the Test product – Paliperidone Palmitate 156 mg/ml Injectable Suspension of Amneal Pharmaceuticals Company GmbH, compared to INVEGA® SUSTENNA® (paliperidone palmitate) extended-release injectable suspension 156 mg/ml Manufactured for Janssen Pharmaceuticals, Inc.
时间窗: Day 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309
次要结局
- To monitor the safety and tolerability of Paliperidone Palmitate 156 mg/ml Injectable Suspension in schizophrenia patients who are already receiving a stable regimen of Paliperidone Palmitate extended release suspension via the intramuscular route.(Throughout Study Period)