CTRI/2026/07/114199进行中（未招募）不适用
An Open-label, Multicenter, Randomized, Two Treatment, Two Period, Two Sequence, Steady state Crossover, Multiple Dose, Bioequivalence Study of Test Product Clozapine Tablets USP 100 mg of Unichem Laboratories Ltd, India with Reference Product CLOZARIL [Clozapine] Tablets 100 mg of HLS Therapeutics [USA], Inc. Rosemont, PA 19010 in Adult Participants with Schizophrenia Receiving Stable Dose of Clozapine under Fasting Condition. - NIL
Unichem Laboratories Limited.0 个研究点目标入组 42 人开始时间: 2026年8月14日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
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
- •Participant will be eligible for inclusion in this study only if all of the following criteria apply:
- •Male or non-pregnant, non-lactating female participant aged between 18 to 60 years [completed years].
- •Participant who is diagnosed with schizophrenia, according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition [DSM-V] criteria [Appendix I].
- •Participant who has been receiving a stable dose of clozapine at the same multiples of 100 mg every 12 hours for at least three months.
- •Participant have a diagnosis of treatment-resistant schizophrenia.
- •Participant with Body mass index between 18.5 to 30.0 kg per meter square [both inclusive].
- •Participant having adequate hematologic functions at screening:
- •a. Absolute neutrophil count Greater Than or Equal to 2000 per mm3
- •b. WBC count Greater Than or Equal to 4000 per mm3
- •c. Platelet count Greater Than or Equal to 100,000 per mm3
- •Participant having adequate and stable hepatic function, lipid profile, and renal function at screening:
- •a. Bilirubin Less than or Equal to 1.5 Multiply by ULN [Upper limit of normal]
- •b. AST or ALT Less than or Equal to 1.5 Multiply by ULN
- •c. Total Triglyceride Less than or Equal to 1.5 Multiply by ULN
- •d. Total cholesterol Less than or Equal to 1.5 Multiply by ULN
- •e. Creatinine Less than or Equal to 1.5 Multiply by ULN
- •Non-smoker [i.e., having no past history of smoking for at least one year prior to screening].
- •Female participant with postmenopausal status or female of childbearing potential with negative pregnancy test must agree to practice an acceptable method of contraception throughout the study period and for at least 6 months after last dose of IP. Postmenopausal is defined by any one of the following:
- •a. Postmenopausal with spontaneous amenorrhea for at least one year, or
- •b. 6 months to 12 months of spontaneous amenorrhea with serum FSH levels Greater Than 40 mIU per mL. or
- •c. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
- •d. Total hysterectomy and an absence of bleeding for at least 3 months.
- •Participant willing and able to comply with the protocol requirements.
- •Participant or LAR willing to provide informed consent to participate in the study.
排除标准
- •Participant will not be eligible for inclusion in this study if any of the following criteria apply:
- •History of suicidal tendencies [e.g. suicidal attempts] or immediate risk of harm to self or others within the past 3 months prior to screening, as judged by the investigator.
- •Participant diagnosed dementia related psychosis.
- •Participant with medical or surgical condition that might interfere with the absorption, metabolism, or excretion of Clozapine or other study medications.
- •Participants who require dose modification of clozapine treatment during the study period, as per the Principal Investigators opinion.
- •Participant with history of granulocytopenia or myeloproliferative disorder, either drug induced or idiopathic.
- •Participant with any significant disease or condition which might compromise the hemopoietic, gastrointestinal [e.g., pancreatitis], renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis, or any other body system.
- •Participant with history of Neuroleptic Malignant Syndrome.
- •Participant with history of any significant disease or condition related to cardiovascular system like myocarditis, pericarditis, cardiomyopathy and mitral valve.
- •History of uncontrolled diabetes [HbA1c Greater Than 10 Percenrtage], severe allergic reaction.
- •Participant with serum positivity for Hepatitis B, C, or HIV at screening visit.
- •Participant with history of epilepsy or seizures or is comatose or experiencing severe central nervous system depression.
- •Participant with history of allergic reactions to Clozapine or chemically related psychotropic drugs.
- •Participant with hypomagnesemia [defined as serum magnesium Less Than Lower limit of normal - LLN], hypokalemia [defined as serum or plasma potassium Less Than LLN] at screening visit.
- •Acute psychotic exacerbations within 3 months prior to screening visit.
- •Participant having concurrent neurological diagnosis, including mental retardation, severe tardive dyskinesia, or idiopathic Parkinsons disease.
- •QTc [Heart Rate Corrected QT interval] Greater Than 450 msec [male] or Greater Than 470 msec [female] or family history of long QT syndrome. QT interval will be calculated with Bazetts Formula at screening visit [Appendix II].
- •Participant who had undergone electroconvulsive therapy within 3 months prior to screening visit.
- •Participant had demonstrated clinically significant homicidal behavior within 1 year prior to screening visit.
- •Participation in any investigational drug study within 30 days prior to screening visit.
- •History of an inherited hyperlipidemia or metabolic syndrome.
- •Participant had history of narrow-angle glaucoma.
- •Participant had history of multiple syncopal episodes.
- •Significant orthostatic hypotension [i.e., a drop in systolic blood pressure of 30 mm Hg or more and or a drop in diastolic blood pressure of 20 mm Hg or more on standing] at screening visit.
- •Concurrent use of antihypertensive medication or any medication that might predispose to orthostatic hypotension.
- •Substance abuse or alcohol dependence during the 6-month period immediately prior to screening visit [except dependence in full remission].
- •Use of any medication known to in
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