CTRI/2016/07/007083已完成未知
A Multicentric, Open-label, Randomized, Two-treatment, Two-sequence, Two-period, Crossover, Steady-state Clinical Bioequivalence Study of ZIPROC-100 (Clozapine) 100 mg Tablets of Torrent Pharma Philippines Inc., Philippines (Test) with LEPONEX®(Clozapine) 100 mg tablets of Novartis Healthcare Philippines, Inc., Philippines (Reference) in Schizophrenic Patients who are Receiving Stable Daily Dose of Clozapine 100 mg BID under Fasting Conditions - None
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 56
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
- •Patients of either sex, aged 18 to 55 years (both inclusive) having clinical diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria (DSM-V TR)
- •Patients with body mass index between 18 and 25 kg/m2
- •Patients who are appropriate candidates for Clozapine therapy (as stated in ZIPROC-100 and LEPONEX® package inserts) and have been taking a stable dose of Clozapine 100 mg twice daily for at least three months before enrolment in the study
- •Patients who are healthy as determined by physical examination, medical history, and no significant abnormality in any of the laboratory parameters, including electrocardiogram and Chest x-ray
- •Ability to comprehend the full nature and purpose of the study, including possible risks and adverse events (AEs); ability to co-operate with the investigator and study team and to comply with the requirements of the entire study
- •Patients/legally acceptable representative has given written consent after being advised of the nature and risks of the study
- •Patients must have adequate hematologic reserve:
- •Hemoglobin (Hb) >= 11 gm/dL
- •White blood cells (WBC) >= 4000 /mm3 or /μL
- •Platelets >= 100,000 mm3 or /μL
- •Absolute neutrophil count (ANC) >= 2000 /mm3 or /μL
- •Adequate and stable hepatic function at screening as defined by:
- •Bilirubin <= 1.5 Ã? ULN (upper limit of normal)
- •Aspartate aminotransferase/alanine aminotransferase (AST/
- •ALT) <= 1.5 Ã? ULN
- •Total triglycerides <= 1.5 Ã? ULN
- •Total cholesterol <= 1.5 Ã? ULN
- •Adequate renal function at screening as defined by:
- •Creatinine <= ULN for the clinical laboratory
- •Serum potassium <= ULN
- •Serum magnesium <= ULN
- •Female patients of childbearing potential must have a negative urine pregnancy test at screening and check-in
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
- •Elderly patients with diagnosed dementia related psychosis
- •Patients with medical or surgical condition that might interfere with the absorption, metabolism, or excretion of Clozapine or other study medications
- •Patients with history of granulocytopenia or myeloproliferative disorder, either drug-induced or idiopathic
- •Patients with history of clinically significant cardiovascular, renal, hepatic, respiratory, endocrine (except noninsulin-dependent diabetes mellitus), or gastrointestinal disease
- •Patientâ??s positive for HIV, HBs Ag or HCV
- •Patients with history of epilepsy or seizures or are comatose or experiencing severe central nervous system depression
- •Patients who are unable to communicate with the investigator and study team
- •Patients with a history of allergic reactions to Clozapine or chemically related psychotropic drugs
- •Patients having concurrent primary psychiatric or neurological diagnosis, including organic mental disorder (DSM-V criteria), mental retardation, severe tardive dyskinesia, or idiopathic Parkinsonâ??s disease
- •Patients who had undergone electroconvulsive therapy within the past 1 month
- •Patients have demonstrated clinically significant homicidal behaviour within the past 12 months
- •Patients have received any investigational drug within the past 90 days
- •Patients having a history of narrow-angle glaucoma
- •Patients requiring 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 with 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)
- •Concurrent use of antihypertensive medication or any medication that might pre-dispose to orthostatic hypotension
- •Positive tests for drug or alcohol abuse at screening and before check-in
- •A history of alcohol or drug dependence by DSM-V criteria during the 6-month period immediately prior to study entry
- •History of multiple syncopal episodes
- •Patients who smoke more than 10 cigarettes / day or unable to abstain from smoking during the study
- •Expected changes in concomitant medication during the period of study
研究者
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