CTRI/2013/06/003745已完成未知
A multicenter, open-label, randomized, two-treatment, two- sequence, two-period, cross-over, steady-state clinicalBio-equivalence study of Clozapine 100 mg tablet of Aurobindo (test) with Clozaril® (Clozapine) 100 mg tablet of Novartis (reference) in schizophrenic patients already receiving/ stabilized with Clozapine under fasting conditions.
Aurobindo Pharma Limited0 个研究点目标入组 36 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 36
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)Patients have a diagnosis of a) treatment-resistant schizophrenia or; b)schizophrenia, chronic (all types) and in a residual phase or in remission, or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria
- •2)Body mass index between 18 and 35kg/m2 aged between 18 and 60 years
- •3)Patients should be appropriate candidates for Clozapine therapy (as stated in product labeling) and have been taking a stable dose of Clozapine for at least three months.
- •4) Patients who are already receiving/ stabilized on Clozapine daily dose of 100mg twice daily (100 mg Q12h).
- •5)Patients should be otherwise healthy as determined by physical examination, medical history, and no significant abnormality in any of the laboratory parameters including ECG and Chest X-ray.
- •6)Ability to comprehend the full nature and purpose of the study, including possible risks and adverse events; ability to co-operate with the Investigator and to comply with the requirements of the entire study.
- •7)Patients/Legal Representative has given written consent after being advised of the nature and risks of the study.
- •8)Patients must have adequate hematologic reserve
- •I.Hemoglobin >=10gm/dL
- •II.WBC (white blood cells) >4000/mm3
- •III.Platelets >=100,000/mm3
- •IV.ANC (absolute neutrophils count) >2000/mm3
- •9) Adequate and stable hepatic function at screening as defined by:
- •I.Bilirubin <1.5 X ULN (upper limit of normal)
- •II.AST/ ALT <1.5 X ULN
- •III.Total Triglycerides <1.5 X ULN
- •IV.Total Cholesterol <1.5 X ULN
- •10) Adequate renal function at screening as defined by:
- •I.Creatinine <1.5 X ULN for the clinical laboratory
- •11) Female subjects of childbearing potential must have a negative serum pregnancy test at enrolment
排除标准
- •1)History of suicidal tendencies (e.g. suicidal attempts) within the past 3 months prior to screening or immediate risk of harm to self or other at the time of Screening, as judged by the investigator.
- •2)Absolute neutrophil count <= 2000/mm3 and WBC count <= 4000/mm3.
- •3)Elderly patients with diagonosed dementia related psychosis.
- •4)Patients have a medical or surgical condition that might interfere with the absorption, metabolism, or excretion of Clozapine or other study medications.
- •5)Patients have a history of granulocytopenia or myeloproliferative disorder, either drug-induced or idiopathic.
- •6)Patients have a history of clinically significant cardiovascular, renal, hepatic,respiratory, endocrine (except noninsulin-dependent diabetes mellitus), or gastrointestinal disease.
- •7)Patients have a known history of human immunodeficiency virus infection.
- •8)Patients have a history of epilepsy or seizures or are comatose or experiencing severe central nervous system depression.
- •9)Patients are unable to communicate with the investigator.
- •10)Patients have a history of allergic reactions to Clozapine or chemically related psychotropic drugs.
- •11)Patients have a concurrent primary psychiatric or neurological diagnosis, including organic mental disorder (DSM-IV criteria), mental retardation, severe tardive dyskinesia, or idiopathic Parkinsonâ??s disease.
- •12)Patients have had electroconvulsive therapy within the past one month.
- •13)Patients have demonstrated clinically significant homicidal behavior within the past 12 months.
- •14) Patients have received an investigational drug within the past 90 days.
- •15) Patients have a history of narrow-angle glaucoma.
- •16) Patients require treatment with drugs that are known to interact with Clozapine (e.g., agents having a well-known potential to suppress bone-marrow functioning, drugs that are highly protein-bound, cimetidine, or phenytoin). Clozapine may also potentiate the effects of antihypertensive and anticholinergics; therefore,
- •caution should be taken if patients receiving these drugs are enrolled in the study.
- •17) Patients have a known history of phenylketonuria.
- •18) 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)
- •19) Concurrent use of antihypertensive medication or any medication that might predispose to orthostatic hypotension.
- •20)Concurrent use of other drugs known to suppress bone marrow function.
- •21)Positive tests for drug or alcohol abuse at screening or baseline.
- •22)A history of alcohol or drug dependence by Diagnostic and statistical manual of Mental Disorders IV (DSM-IV) criteria during the 6-month period immediately prior to study entry.
- •23)History of multiple syncopal episodes.
- •24)Patients who smokes.
- •25)Expected changes in concomitant medication during the period of study
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