A Pivotal, Multiple-Dose, Pharmacokinetic Bioequivalence Trial Comparing Generic to Reference Medicinal Product of Paliperidone Palmitate Prolonged-Release Injectable Suspension (100 mg) 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
- 320
- 试验地点
- 13
- 主要终点
- To establish the multiple dose steady-state bioequivalence of equivalent doses of TEST [PP-PRIS 100 mg (Tolmar)] and RMP [Xeplion 100 mg (Janssen-Cilag International NV)]
研究概览
简要总结
The Study isA Pivotal, Multiple-Dose, Pharmacokinetic Bioequivalence Trial Comparing Generic to Reference Medicinal Product of Paliperidone Palmitate Prolonged-Release Injectable Suspension (100 mg) in Subjects with Schizophrenia
Primary Objective: To establish the multiple dose steady-state bioequivalence of equivalent doses of TEST [PP-PRIS 100 mg (Tolmar)] and RMP [Xeplion 100 mg (Janssen-Cilag International NV)]
Secondary Objective: To assess safety and tolerability of RMP and TEST in subjects who are exposed to the investigational product (IP; either TEST or RMP).
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
- •Able to understand the investigational nature of this study and provide written informed consent prior to the participation in the trial 2.Subjects between 18 and 65 years of age (both inclusive)
- •Subjects having body mass index (BMI) between 18.50 to 30.00 kg/m2 (both inclusive)
- •Subjects diagnosed with schizophrenia as per DSM-IV-TR (or later) criteria.
- •Acceptable hematology status: a.
- •Hemoglobin ≥ 9 g/dL b.
- •Absolute neutrophil count (ANC) ≥ 1500 cells/μL c.
- •Platelet count ≥ 100,000 cells/μL
- •Acceptable liver function: a.
- •Alanine aminotransferase (ALT) ≤ 2X upper limit of normal (ULN) b.
- •Aspartate aminotransferase (AST) ≤ 2X ULN c.
- •Bilirubin < 1.2 mg/dL d.
- •Alkaline phosphatase ≤ 2X ULN
- •Subjects with creatinine clearance ≥ 80 mL/minute
- •Female subjects with negative serum pregnancy test at screening.
- •Subjects who agree to use adequate contraception (e.g., hormonal, chemical, double-barrier, or abstinence) while in the study and for 3 months after study participation is discontinued
- •No history of addiction to any recreational drug or drug dependence or alcohol addiction within 12 months prior to randomization
- •Must be able to attend regularly scheduled study center appointments and be able to abide by all study requirements.
排除标准
- •Hypersensitivity to paliperidone palmitate or risperidone or to any of the excipients of the formulations
- •Subjects who are in an acutely agitated or severely psychotic state
- •Subjects who have current thoughts of suicide (suicidal ideation) or violent tendencies at the time of screening
- •Subjects who have a Rating of >4 (moderately ill) on the CGI-S scale at screening
- •History or presence of neuroleptic malignant syndrome (NMS), tardive dyskinesia, dementia-related psychosis, Parkinson’s disease or epilepsy/seizures
- •History or presence of any uncontrolled debilitating systemic disease (e.g., cardiovascular disease, hypertension, diabetes mellitus etc.)
- •Current or anticipated use during study participation of any of the prohibited medications.
- •(See Appendix 14.1)
- •Subjects with congenital long QT syndrome (QTc of > 470 msec for females and > 450 msec for males) or presence of severe cardiovascular disease defined as having required cardiovascular surgery or the occurrence of incapacitating myocardial infarction within past 12 months 9.Subjects with history of arrhythmia
- •Subjects with positive urine screen for drugs of abuse (Except for benzodiazepine which is a permissible medication supported by prescription)
- •Smokers who smoke ≥ 10 cigarettes or equivalent per day
- •Major surgical procedure (including periodontal) within 28 days of first IP dosing
- •Current surgical or other non-healing wounds
- •Subjects with positive serology for hepatitis B virus (HBV), 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 or that could limit adherence to study requirements
- •Participation in any clinical study within 90 days of first IP dosing
- •Donation and/or loss of ≥ 350 mL (1 unit) of blood within 90 days of first IP dosing
- •Lactating women.
结局指标
主要结局
To establish the multiple dose steady-state bioequivalence of equivalent doses of TEST [PP-PRIS 100 mg (Tolmar)] and RMP [Xeplion 100 mg (Janssen-Cilag International NV)]
时间窗: Pre-dose blood sample(within 5minutes prior to dosing)- Day:1,85(Dose-4),113 (Dose-5),141 (Dose-6); Day 142 24 hours; Day 143 48 hours,Day 144 72 hours,Day 145 96 hours(± 60 minutes).Day 146-120 hours, Day 147-144 hours, Day 148-168 hours, Day 149-192 hours, Day 150-216 hours, Day 151-240 hours, Day 152-264 hours, Day 154-312 hours, Day 156-360 hours, Day 158-408 hours, Day 161-480 hours, Day 165-576 hours, Day 169-672 hours (±4 hours)
次要结局
- To assess safety and tolerability of RMP and TEST in subjects who are exposed to the investigational product (IP; either TEST or RMP).(Pre-dose blood sample(within 5minutes prior to dosing)- Day:1,85(Dose-4),113 (Dose-5),141 (Dose-6); Day 142 24 hours; Day 143 48 hours,Day 144 72 hours,Day 145 96 hours(± 60 minutes).Day 146-120 hours, Day 147-144 hours, Day 148-168 hours, Day 149-192 hours, Day 150-216 hours, Day 151-240 hours, Day 152-264 hours, Day 154-312 hours, Day 156-360 hours, Day 158-408 hours, Day 161-480 hours, Day 165-576 hours, Day 169-672 hours (±4 hours))