CTRI/2016/09/007290已完成未知
A randomized, open label, two treatments, two periods, two sequences, multiple dose, crossover, pilot, steady state comparative bioavailability study of Clozapine 300 mg sustained release tablets [OD] of JSC â??Valenta Pharmâ??, Russia and LEPONEX® (Clozapine) 100 mg tablets [TID] of Novartis Pharmaceuticals Ltd, UK, in Schizophrenic patients who are already receiving a stable thrice daily dose of Clozapine 100 mg tablet for at least three months. - None
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 18
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 willing to participate by providing written informed consent.
- •2.Schizophrenic patients aged between 18 to 60 [both inclusive] with a documented clinical diagnosis of schizophrenia according to DSM IV-TR and who are receiving a stable thrice daily dose of Clozapine 100 mg tablet for at least three months.
- •3.Patient having a Body Mass Index (BMI) between 18.00 and 30.00 kg/m2 (Both inclusive),
- •4.Except Schizophrenia otherwise patients should be healthy as determined by physical examination, medical history, and routine hematologic and biochemical tests.
- •5.Patient must be agreeing to - use effective method of contraception while on treatment and for three months after completion of therapy
- •6.Able to comply with study procedures in the opinion of the investigator.
排除标准
- •1.History of allergic reactions to clozapine or other chemically related psychotropic drugs.
- •2.Medical history of clinically significant cardiovascular, renal, hepatic, gastrointestinal disease or blood disorders.
- •3.Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, or idiopathic Parkinsonâ??s disease.
- •4.Patient with history of use of antichloinergic drugs and pateint with history of narrow angle glaucoma.
- •5.HIV, HCV, HBsAg positive.
- •6.Total white blood cell count below 4000/mL, or an absolute neutrophil count below 2000/mL.
- •7.History of granulocytopenia or myeloproliferative disorders (drug-induced or idiopathic)
- •8.Significant orthostatic hypotension (i.e., a drop in systolic blood pressure of 20 mm Hg or more and/or a drop in diastolic blood pressure of 10 mm Hg or more on standing).
- •9.Concurrent use of antihypertensive medication or any medication that might pre¬dispose to orthostatic hypotension.
- •10.Medical or surgical condition that might interfere with the absorption, metabolism, or excretion of clozapine.
- •11.History of epilepsy or risk for seizures.
- •12.Concurrent use of other drugs known to suppress bone marrow function.
- •13.Expected changes in concomitant medications during the period of study.
- •14.Positive tests for drug or alcohol abuse at screening or baseline.
- •15.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.
- •16.Patient unable to comply with the study procedures
- •17.History of multiple syncopal episodes.
- •18.Pregnant or lactating females
- •19.History of significant blood loss due to any reason in the past 3 months.
- •20.Any pre-existing bleeding disorder.
研究者
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