CTRI/2013/06/003745已完成不适用
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 Limited2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2013年6月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- 2)Cmax-ss: Maximum concentration over the steady state dosing interval.
研究概览
简要总结
This study is a randomized, Multicenter, Open-Label, Two-Treatment, Two Sequence, Two-Period, cross over, steady state Clinical Bio-equivalence study to determine multiple oral doses clinical bioequivalence of Clozapine 100 mg tablet of Aurobindo with Clozaril® (Clozapine) 100 mg tablet of Novartis in schizophrenic patient’s already receiving Clozapine 100 mg in stable regimen patients with schizophrenia and this study will be conducted in two centers in India. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
The Primary objective will be to determine clinical bioequivalence of test drug with the active comparator (reference drug). The secondary objective of the study is to monitor the adverse events, to ensure safety and tolerability as assessed by reported adverse events, laboratory, clinical investigations and vital signs in the schizophrenic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
- •Patients who are already receiving/ stabilized on Clozapine daily dose of 100mg twice daily (100 mg Q12h).
- •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.
- •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.
- •Patients/Legal Representative has given written consent after being advised of the nature and risks of the study.
- •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
- •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.
- •Absolute neutrophil count ≤ 2000/mm3 and WBC count ≤ 4000/mm
- •Patients have a medical or surgical condition that might interfere with the absorption, metabolism, or excretion of Clozapine or other study medications.
- •Patients have a history of granulocytopenia or myeloproliferative disorder, either drug-induced or idiopathic.
- •Patients have a history of clinically significant cardiovascular, renal, hepatic,respiratory, endocrine (except noninsulin-dependent diabetes mellitus), or gastrointestinal disease.
- •Patients have a known history of human immunodeficiency virus infection.
- •Patients have a history of epilepsy or seizures or are comatose or experiencing severe central nervous system depression.
- •Patients are unable to communicate with the investigator.
- •Patients have a history of allergic reactions to Clozapine or chemically related psychotropic drugs.
- •Patients have a concurrent primary psychiatric or neurological diagnosis, including organic mental disorder (DSM-IV criteria), mental retardation, severe tardive dyskinesia, or idiopathic Parkinson’s disease.
- •Patients have had electroconvulsive therapy within the past one month.
- •Patients have demonstrated clinically significant homicidal behavior within the past 12 months.
- •Patients have received an investigational drug within the past 90 days.
- •Patients have a history of narrow-angle glaucoma.
- •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.
- •Patients have a known history of phenylketonuria.
- •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.
- •Concurrent use of other drugs known to suppress bone marrow function.
- •Positive tests for drug or alcohol abuse at screening or baseline.
- •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.
- •History of multiple syncopal episodes.
- •Patients who smokes.
结局指标
主要结局
2)Cmax-ss: Maximum concentration over the steady state dosing interval.
时间窗: Day 7, 8, 9, 10 and Day 17,18,19,20
1)AUC0- : Area under the plasma concentration – time curve over the steady state dosing interval.
时间窗: Day 7, 8, 9, 10 and Day 17,18,19,20
3)Cmin-ss: Minimum concentration over the steady state dosing interval
时间窗: Day 7, 8, 9, 10 and Day 17,18,19,20
次要结局
- 1. Css-avg: Average concentration over the steady state dosing interval(2.Percentage fluctuation)
研究者
研究点 (2)
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