CTRI/2022/03/041289进行中（未招募）未知
A Randomised, Open-Label, Two-Treatment, Two-Period, Two-Sequence, Multicentre, Multiple-Dose, Steady-State, Replicate, Crossover, Bioequivalence Study of Aripiprazole 400 mg Powder and Solvent for Prolonged-Release Suspension for Injection of Sun Pharmaceutical Industries Limited compared to Abilify Maintena 400 mg Powder and Solvent for Prolonged-Release Suspension for Injection of Otsuka Pharmaceutical Europe Ltd. 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 ââ?¬â?? 5th edition (DSM-V) or latest version criteria.
- •3.Patient with Body Mass Index (BMI) greater than or equal to 18 to less than 30 kg per m2 and weight not less than 50 kg.
- •4.Patient who is clinically stable and had no hospitalisation for exacerbation of psychiatric symptoms during the 3 months before screening and till randomisation.
- •5.Patient who is currently stable on a regimen consisting of 400 mg of Aripiprazole Prolonged or 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 randomisation.
- •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 Prolonged or 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 agrees to comply with the visit schedule and other requirements of the study.
排除标准
- •1.Patient with known or suspected allergy or hypersensitivity to aripiprazole or any other ingredients 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 investigatorââ?¬•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 Investigatorââ?¬•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 metaboliser of CYP2D6 enzyme.
- •6.Patient with Clinical Global Impression - Severity of illness (CGI-S) 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 (NMS) or tardive dyskinesia while on treatment with atypical antipsychotics.
- •9.Patient with dementia related psychosis.
- •10.Patient with history or presence of pathological gambling and other compulsive behaviours.
- •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 greater than or equal to 20 mmHg or diastolic BP of greater than or equal to 10 mmHg when comparing standing to supine values) or uncontrolled hypertension (systolic BP greater than or equal to 150 mmHg or diastolic BP greater than or equal to 100 mmHg).
- •13.Patient with known cardiovascular disease (example, heart failure, history of myocardial infarction or ischaemia), cerebrovascular disease, or conditions that predispose the patient to hypotension (example, dehydration, hypovolemia, and treatment with antihypertensive medications), uncontrolled metabolic disorders including uncontrolled hyperglycaemia/diabetes mellitus (HbA1c greater than or equal to 9 percent) or dyslipidaemia.
- •14.Patient with a history of a corrected QT interval greater than 450 ms (Bazettââ?¬•s formula).
- •15.Patient with history of drug induced leukopenia or neutropenia or agranulocytosis.
- •16.Patient with abnormal haematological parameters at screening and randomisation defined by:
- •a.Total white blood cell count less than 4000 per mm3
- •b.ANC less than 1500 per mm3
- •c.Platelet count less than 100,000 per mm3
- •d.Haemoglobin less than 9.0 gm per dl
- •17.Patient with abnormal liver function tests at screening and randomisation as defined by:
- •a.Bilirubin greater than 1.5 X ULN
- •b.AST and ALT greater than 5 X ULN
- •18.History of alcohol or substance abuse during the 6-months period immediately prior to screening.
- •19.Patients who smokes or chew tobacco products.
- •20.Any changes in antipsychotic medication or dosage except aripiprazole during the past 3 months prior to the ra
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