CTRI/2018/04/013054招募中1 期
A Multicentric, Open Label, Randomized, Two-Treatment, Two-sequence, Two-period, Cross-over, Multiple dose, Steady-state Clinical Bioequivalence Study of Clozapine Tablets USP 100 mg of Alkem Laboratories Limited, India (Test) with CLOPINE® 100 mg (Clozapine) tablets, Hospira Australia Pty Ltd (Reference) in Patients with Schizophrenia under Fasting conditions.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
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.Patient diagnosed with 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, Fifth Edition (DSM-V) criteria.
- •2.Patient with Body mass index between 18.5 to 30 kg/m2 (both inclusive) and aged between 18 to 55 years (both inclusive).
- •3.Patient is on for Clozapine therapy and has been taking a stable dose of Clozapine Tablets 100 mg twice daily for at least three months before enrolment in the study.
- •4.Patient having adequate hematologic reserve at screening as per principal investigator assessment.
- •5.Patient having adequate and stable hepatic function and renal function at screening as per principal investigator assessment.
- •6.Patient should have no clinically significant abnormality in any of the laboratory parameters including ECG and Chest X-ray as per the discretion of Principal Investigator.
- •7.Patient and Legally Acceptable Representative had given consent after being advised of the nature and risks of the study.
- •8.Female patient of childbearing potential must have a negative serum pregnancy test at screening.
- •9.Patient agreed to use acceptable methods of birth control as directed by study team.
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 or /µL and WBC count = 4000 /mm3 or /µL.
- •3.Elderly patient with diagnosed dementia related psychosis.
- •4.Patient with medical or surgical condition that might interfere with the absorption, metabolism, or excretion of Clozapine or other study medications.
- •5.Patient with history of granulocytopenia or myeloproliferative disorder, either drug-induced or idiopathic.
- •6.Patient with history of clinically significant cardiovascular, renal, hepatic, respiratory, endocrine (except noninsulin-dependent diabetes mellitus), or gastrointestinal disease.
- •7.Patient found to be positive for HIV, HBsAg or HCV.
- •8.Patient with history of epilepsy or seizures or are comatose or experiencing severe central nervous system depression.
- •9.Patient is unable to communicate with the investigator.
- •10.Patients with history of allergic reactions to Clozapine or chemically related psychotropic drugs.
- •11.Patients having concurrent neurological diagnosis, including mental retardation, severe tardive dyskinesia, or idiopathic Parkinson’s disease.
- •12.Patients who had undergone electroconvulsive therapy within the past one month.
- •13.Patient had demonstrated clinically significant homicidal behavior within the past 12 months.
- •14.Patient had received any investigational drug within the past 90 days.
- •15.Patient had history of narrow-angle glaucoma.
- •16.Patient with known history of phenylketonuria.
- •17.Patient with known history of 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).
- •18.Patient with uncontrolled hypertension as per the discretion of PI
- •19.Patient is on concurrent use of other drugs known to suppress bone marrow function.
- •20.Patient had history of multiple syncopal episodes.
研究者
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