CTRI/2023/06/054479进行中（未招募）不适用
A Randomized, Open Label, Multicenter, Multiple Dose, Two-stage, Two-treatment, Two-period, Two-way, Crossover Steady State Bioequivalence Study between Paliperidone Palmitate extended-release intramuscular injectable suspension (156 mg/mL) of American Regent, Inc. Shirley, NY 11967, USA & INVEGA SUSTENNA® Kit (paliperidone palmitate) extended release intramuscular injectable suspension (156 mg/mL) manufactured for Janssen Pharmaceuticals, Inc. Titusville, NJ 08560, USA in adult patients with schizophrenia and schizoaffective disorder.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 170
- 试验地点
- 15
- 主要终点
- To establish bioequivalence between the American Regent Inc. Test Product of Paliperidone Palmitate extended-release intramuscular injectable suspension (156 mg/mL) & the Reference Product INVEGA SUSTENNA® kit (paliperidone palmitate) extended-release intramuscular injectable suspension (156 mg/mL) in adult patients with schizophrenia & schizoaffective disorders.
研究概览
简要总结
Upon entering into the study, patients will receive the Injection Paliperidone Palmitate extended release injectable suspension for intramuscular use 156 mg, Intra muscularly (Deltoid site) every month for a total of 5 doses at ambient temperature as per randomization schedule (either the test or reference product) in a parallel design. Investigational product administration will be done by the trained study personnel under the supervision of the investigator.
- During the Stabilization period, participants will receive monthly doses of an approved marketed version of paliperidone palmitate 156 mg (100 mg Paliperidone) extended-release injectable suspension. Details of the same will be included in IMP plan.
- During the study, participants will receive test or reference product, as per the randomization sequence, every 1 months. Each participant will receive a total of 5 doses in each period.
- Paliperidone Palmitate extended-release injectable suspension for intramuscular use 156 mg/mL (100 mg Paliperidone) (test or reference product) will be administered intramuscularly in the deltoid/gluteal muscle of each participant on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, and 253.
- Decision to inject IMP in deltoid or gluteal region will be decided by investigator based on their evaluation of participants. Administration site that i.e., deltoid/gluteal will remain consistence across all the doses and both the periods.
- After the study is completed (after last PK sample collection on Day 281), patients may be continued on their current dose of Paliperidone using an approved paliperidone product as prescribed by their clinicians.
· Administration shall be performed on alternating body sides (left and right) for each injection.
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
- •Male & Female having a documented clinical diagnosis of schizophrenia or schizoaffective disorder according to the PI evaluation and Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V).
- •2.Participant is willing to participate for the entire study and adhere to the study protocol and committed for required clinic visits and dosing.
- •3.Written informed consent for participation in the study by the participant and participant’s legally acceptable representative (LAR) and willing to adhere to protocol requirements.
- •Participants having BMI between ≥18-35 kg / m2 and at least 50 kg weight for male participants and 48 kg for female participants.
- •5.Participants who at screening are at a stable regimen of oral Paliperidone or Risperidone therapy or who are already receiving Paliperidone palmitate 156 mg/mL (100 mg Paliperidone) extended-release intramuscular injectable suspension and who at randomization are receiving a stable regimen of 156 mg/mL (100 mg Paliperidone) of monthly paliperidone palmitate extended-release suspension via the intramuscular route.
- •7.Participants having treatment response score of < 4 (unchanged or worse and side-effects outweigh the therapeutic effects) as evaluated using Clinical Global Impression scale by investigator at both screening and Baseline visits.
- •8.Participants not having any significant diseases or clinically significant abnormal findings except schizophrenia during screening.
- •9.In case of Male participants: Either partner or participant must use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during the study and till the end of study.
- •Cessation of birth control after this point should be discussed with a responsible physician.
- •10.Women of non-childbearing potential with documented evidence of hysterectomy / bilateral salpingectomy / bilateral oophorectomy at least 6 months prior to IMP administration) or postmenopausal for at least 12 consecutive months.
排除标准
- •Participants who meet any of the following criteria will not be enrolled in the study: 1.Participant with known hypersensitivity and/or intolerance to study drug or any other component of the drug or intolerance to oral paliperidone/risperidone prior to screening.
- •2.Pregnant or participants with childbearing potential not practicing contraceptive or other barriers of contraception.
- •3.Participants with a history of Neuroleptic Malignant Syndrome (NMS) while on treatment with antipsychotics.
- •4.History or presence of clinically significant cardiovascular disease, especially known history of QT prolongation, congenital long QT syndrome, recent acute myocardial infarction, cardiac arrythmias or uncompensated heart failure.
- •5.Participants with the QT prolongation risk (torsade de pointes and/or conditions that can lead to sudden death or participants receiving drugs that prolong QTc interval, including: bradycardia, cardiac arrhythmias, hypokalemia or hypomagnesemia, concomitant use of other drugs that known to prolong the QTc interval, and prolonged QT interval (QTc> 450 msec in male participants or QTc> 470 msec in female participants, QTc interval to be calculated with Bazett’s Formula) at screening and randomization.
- •6.Participants with current or relevant history of psychiatric illness except schizophrenia.
- •7.Participants with clinically significant illnesses or Participant had major surgery within 4 weeks prior to first dosing, or who have not recovered from prior major surgery.
- •Participants with concurrent condition of Parkinson disease (except for drug-induced extrapyramidal syndrome).
- •Participants with history or presence of tardive dyskinesia.
- •Participants with cognitive and motor impairment.
- •9.Participants with concomitant treatment with hepatic enzyme inhibitors (including fluoxetine or paroxetine) or medications known to interact with study medication within 2 weeks of the first injection of study medication.
- •10.Treatment with any of the following therapies: •Injection of risperidone long-acting injection within 6 weeks before randomization.
- •â€¢Electroconvulsive therapy within 3 months prior to screening.
- •â€¢Clozapine within 3 months before screening.
- •11.Presence of syncope or orthostatic hypotension (defined as systolic blood pressure decrease of at least 30 mmHg or a diastolic blood pressure decrease of at least 20 mmHg within one to three minutes of standing up).
- •12.Participants with uncontrolled hypertension (systolic BP ≥ 150 mmHg/diastolic BP ≥ 100 mmHg).
- •13.Participants with known cerebrovascular disease, or conditions that predispose the participant to hypotension (e.g., dehydration, hypovolemia and treatment with antihypertensive medications).
- •14.Participants with inadequate mass in the deltoid/gluteal regions to receive the intramuscular drug injection.
- •15.Participants with severe hepatic impairment based on the Child-Pugh classification (Child-Pugh category C).
- •16.Participants with a history of alcohol or drug-dependence as per DSM-V criteria during the 6-month period prior to screening.
- •17.Donation of blood (≥ 1 unit or 350 mL) within 90 days prior to receiving the first dose of study medication or during the study.
- •18.Participant attempted suicide within 12 months before screening or current thoughts of suicide (suicidal ideation) or violent tendencies/ behavior as clinically assessed by the investigator based on Columbia Suicide Severity Rating Scale (CSSRS).
- •19.Participants found positive for HIV, Syphilis, Hepatitis B surface antigen or Hepatitis C antibody at screening.
- •20.Participants with suspected signs and symptoms of COVID-19 / those positive for novel coronavirus infection (COVID-19) within 14 days of screening or with a recent history of travel (14 days)/ contact with any COVID-19 positive subject/isolation/quarantine.
- •21.Smokers who smoke greater than or equal to 10 cigarettes or equivalent per day.
- •22.Current surgical or other non-healing wounds or major surgical procedure (including periodontal) within 28 days of first study dose of IP.
- •24.Participant positive on Breath alcohol analyzer test at the time of visit at screening and baseline.
- •25.Treatment with any investigational drug in the last 3 months (or 5 half-lives, whichever is longer) before signing the informed consent.
- •26.Psychosis judged to be the direct physiological effect of an abused medication or substance.
- •27.Participants with the following cardiac conditions: •Recent myocardial infarction (<12 months) •First-degree heart block with PR interval > 0.22 seconds.
- •â€¢Sustained cardiac arrhythmia or history of sustained cardiac arrhythmia •Uncompensated congestive heart failure, myocarditis, cardiomyopathy •Complete left bundle branch block.
- •28.Participants with uncontrolled Diabetes mellitus (HbA1c ≥ 9 %) at the time of screening.
- •29.A history of epilepsy or multiple syncopal episodes.
- •30.Participants with hyperprolactinemia or with possible prolactin dependent tumor at screening visit which as judged by the Investigator could lead to safety risk to the participant upon participation in the trial or could interfere with the conduct of the trial.
- •31.Participants with dementia related psychosis.
- •32.Concurrent use of other drugs known to suppress bone marrow function.
- •34.Participants who, in the opinion of the Investigator, will not be compliant with the requirements of the study procedures.
- •35.History of difficulty in accessibility of veins or intolerance to direct venipuncture.
- •36.Positive on urine test for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine) at the time of screening visit and prior to receiving the first dose of investigational medicinal product in the study.
- •Note: If the participant is taking benzodiazepines in the therapeutic doses under the guidance of a psychiatrist, then this participant will not be excluded from study.
结局指标
主要结局
To establish bioequivalence between the American Regent Inc. Test Product of Paliperidone Palmitate extended-release intramuscular injectable suspension (156 mg/mL) & the Reference Product INVEGA SUSTENNA® kit (paliperidone palmitate) extended-release intramuscular injectable suspension (156 mg/mL) in adult patients with schizophrenia & schizoaffective disorders.
时间窗: A total of 58 blood samples each of 03 mL will be collected from each participantfor PK assessment | during the study. All the post-dose PK blood samples till 48.00 hr. should be collected within ± | 2 minutes from the scheduled sampling time.
次要结局
- To document the safety & tolerability of paliperidone palmitate intramuscular injections (test and reference products) in adult patients with schizophrenia and schizoaffective disorders(At Screening, at each dosing (at the time of check in on days 0, 140, 112 & 252) and end of study (EOS) visit, there will be physical examination, vitals signs will be performed by investigator.)
研究者
研究点 (15)
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