CTRI/2023/06/054479招募中Unknown
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. - NI
试验速览
- 阶段
- Unknown
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. 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.
- •4. 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.
- •6.Participants who are clinically stable and not hospitalized for exacerbation of psychiatric symptoms for at least 3 months before randomization.
- •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.
- •8. 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.
- •Electroconvulsive therapy within 3 months prior to screening.
- •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
研究者
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