CTRI/2022/03/040805进行中（未招募）未知
A Randomized, Open-Label, Two-Treatment, Two-Period, Two-Sequence, Multicenter, Multiple-Dose, Steady-State, Crossover, Bioequivalence Study of Aripiprazole Extended Release Injectable Suspension 400 mg/vial of Sun Pharmaceutical Industries Limited Compared to ABILIFY MAINTENA® 400 mg/vial of Otsuka America Pharmaceutical Inc., USA in Adult Patients with Schizophrenia under Fasting Condition.
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1.Male or non-pregnant, non-lactating female patient between 18 and 60 years of age (both inclusive).
- •2.Patient with documented diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders â?? 5th edition or latest version criteria.
- •3.Patient with Body Mass Index equal or more than 18 to less than 30 kg/m2 and weight not less than 50 kg.
- •4.Patient who is clinically stable and have had no hospitalization for exacerbation of psychiatric symptoms during the 3 months before screening and till randomization.
- •5.Patient who is currently stable on a regimen consisting of 400 mg of Aripiprazole Extended-Release Injectable Suspension via intramuscular route every four weeks for at least 12 weeks (i.e. at least 3 doses) as judged by the investigator prior to randomization.
- •6.Patient with established tolerability for at least 14 days to oral Aripiprazole prior to screening, if not on a stable monthly regimen of 400 mg of Aripiprazole Extended-Release Injectable Suspension.
- •7.Patient and LAR must demonstrate adequate decision-making ability to make an informed decision about participating in this study by providing written informed consent.
- •8.Patient who agree to comply with the visit schedule and other requirements of the study.
排除标准
- •1.Known or suspected allergy or hypersensitivity to aripiprazole or other constituents of the formulation.
- •2.Patient having signs and symptoms suggestive of COVID-19 (such as fever, dry cough, difficulty in breathing, fatigue etc.).
- •3.History of medically significant adverse events or intolerance with aripiprazole based on investigatorâ??s discretion.
- •4.Patient on drugs known to be inducer or inhibitor of CYP3A4 and CYP2D6 enzymes.
- •a. If the patient was on any of these drugs, sufficient wash out period (of at least 5 half-lives) must have elapsed since the last dose of such drug and the first dose of study medication.
- •b. Individuals with co-administered weak CYP3A4 and CYP2D6 inhibitors will be allowed if on a stable regimen of at least 1 month based on Principal Investigatorâ??s discretion in consultation with Medical Monitor and with plans to remain on that stable regimen throughout the course of this study.
- •5.Patient who is poor metabolizer of CYP2D6 enzyme.
- •6.Patient with Clinical Global Impression â?? Severity of illness score of 5 or more.
- •7.Patient with inadequate muscle mass to receive the intramuscular injection according to the investigator.
- •8.Patient with a history of Neuroleptic Malignant Syndrome or tardive dyskinesia while on treatment with atypical antipsychotics.
- •9.Patient with dementia related psychosis.
- •10.History or presence of pathological gambling and other compulsive behaviors.
- •11.Patient with history or presence of seizures or other conditions that potentially lower the seizure threshold.
- •12.Presence of significant orthostatic hypotension (i.e., decrease in systolic blood pressure equal or more than 20 mmHg or diastolic BP of equal or more than 10 mmHg when comparing standing to supine values) or uncontrolled hypertension (systolic BP equal or more than 150 mmHg/diastolic BP equal or more than 100 mmHg).
- •13.Patient with known cardiovascular disease (example, heart failure, history of myocardial infarction or ischemia), cerebrovascular disease, or conditions that predispose the patient to hypotension (example, dehydration, hypovolemia, and treatment with antihypertensive medications), uncontrolled metabolic disorders including uncontrolled hyperglycemia/diabetes mellitus (HbA1c equal or more than 9 %) or Dyslipidemia.
- •14.Patient with a history of a corrected QT interval more than 450 ms (Bazettâ??s formula).
- •15.History of drug induced leukopenia/ neutropenia/ agranulocytosis.
- •16.Patient with abnormal hematological parameters at screening and randomization defined by:
- •a. Total white blood cell count less than 4000/mm3
- •b. ANC less than 1500/mm3
- •c. Platelet count less than 100,000/mm3
- •d. Hemoglobin less than 9.0 gm/dl
- •17.Patient with abnormal liver function tests at screening and randomization as defined by:
- •a. Bilirubin more than 1.5 X ULN
- •b. AST & ALT more than 5 X ULN
- •18.History of alcohol or substance abuse during the 6-month period immediately prior to screening.
- •19.Any changes in antipsychotic medication or dosage except aripiprazole during the past 3 months prior to the randomization.
- •20.Received Electroconvulsive Therapy within the last 3 months prior to screening.
- •21.Patient with suicidal ideation (score of 4 or 5 on the Columbia Suicide Severity Rating Scale) within the past 2 m
研究者
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