CTRI/2014/04/004524已完成未知
A Randomized, Open Label, Multicentre, Two-Treatment, Two-Period, Two-Sequence, Steady State, Multiple Dose, Crossover, Comparative Bioequivalence Study of CLOZAREM (Clozapine) 100 mg Tablets of Remedica Ltd. with LEPONEX®/ CLOZARIL (Clozapine) 100 mg tablets, Manufactured by Novartis in Adult Patients Suffering from Schizophrenia under Fasting Conditions.
Remedica Ltd0 个研究点目标入组 24 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
- 24
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
- •The Patients who qualify for the study should meet the following inclusion criteria.
- •1. Either sex, aged 18 to 55 years (both inclusive) having clinical diagnosis of schizophrenia (DSM IV-TR)
- •2. Receiving clozapine treatment in divided doses at 12 hours interval for at least 3 months prior to randomization and on 100 mg twice daily dosage at the time of screening.
- •3. Willing and able to comply with study visit schedule and other protocol requirements as indicated by signed written informed consent witnessed by a legally acceptable representative.
- •4. Females of childbearing potential (who has not completed 1 year after menopause & have not gone through hysterectomy or bilateral tubal ligation) must have a negative pregnancy test (at screening, before randomization and before check-in to housing e.g. day 0) as well as must be non-lactating at screening and must agree to use an effective contraceptive method during study.
排除标准
- •The Patients with any of the following criteria should be excluded:
- •1. A history of allergic reactions to clozapine or other chemically related psychotropic drugs
- •2. Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, Alcoholic and other toxic psychoses, severe tardive dyskinesia, or idiopathic Parkinsonâ??s disease
- •3. History of toxic or idiosyncratic granulocytopenia/ agranulocytosis (with the exception of granulocytopenia/ agranulocytosis from previous chemotherapy), benign ethnic neutropenia, clozapine-induced agranulocytosis or myeloproliferative disorders
- •4. History of severe renal or cardiac disorders (e.g. myocarditis), paralytic ileus, prostatic enlargement, narrow-angle glaucoma, colonic disease or lower abdominal surgery, active liver disease associated with nausea, anorexia or jaundice; progressive liver disease, hepatic failure.
- •5. History of multiple syncopal episodes or presence of significant orthostatic hypotension (Defined as a drop in supine systolic blood pressure of 30 mm Hg or more or a drop in supine diastolic blood pressure of 20 mm Hg or more on standing)
- •6. Current/ recent (within 3 months) history of uncontrolled epilepsy or risk for seizures
- •7. A medical or surgical condition that might interfere with the absorption, metabolism, or excretion of clozapine
- •8. Substance abuse or alcohol dependence during the 6-month period immediately prior to study entry (except dependence in full remission), as defined by DSM IV-TR criteria or chronic smoking (greater than or equal to 10 cigarettes or equivalent per day)
- •9. Any of the following laboratory abnormality:
- •WBC count less than 3500 per microliter,
- •Absolute Neutrophil Count less than 2000 per microliter,
- •Absolute Eosinophil Count greater than 3000 per microliter or
- •Platelet count less than 50,000 per microliter
- •Serum creatinine greater than 1.5 mg per deciliter
- •QTc greater than 500 milliseconds
- •SGOT or SGPT greater than 3 times Upper Limit of Normal range (ULN)
- •Bilirubin greater than 1.5 times ULN
- •Reactive to antiHIV, HBsAg, antiHCV
- •10. Use of any of the following in the 14 days preceding enrolment including but not limited to:
- •Drugs significantly influencing CYP1A2 activity.
- •Drugs significantly inhibiting CYP2D6 activity.
- •Medications known to prolong the QTc interval
- •Substances known to have a substantial potential for causing agranulocytosis
- •Phenytoin, lithium
- •highly protein bound substances
- •Antihypertensive and other drugs known to cause postural hypotension.
- •Alcohol, MAOIs, CNS depressants including narcotics and benzodiazepines
- •Antimuscarinic
- •11. Participation in another clinical trial or use of other investigational product/ device within 4 weeks prior enrollment into this study.
- •12. Blood donation/ blood loss exceeding 200 ml within 90 days prior to enrollment in the study.
- •13. Any condition/ Abnormal baseline findings that in the investigatorsâ?? judgment might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study e.g. low expectation of compliance to OPD dosing or expected changes in concomitant medication that may interfere in study.
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