CTRI/2015/07/005980已完成未知
A Randomized, Open-Label, Two Period, Two-Treatment, Two Sequence, Crossover, Multiple-Dose, Steady State, Bioequivalence Study of Clozapine Tablets USP 100 mg of Cadila healthcare Ltd., India with Clozaril® (Clozapine) Tablets 100mg Manufactured by: Novartis Pharmaceutical corporation, Suffern, New York 10901 in Patients with Schizophrenia or Schizoaffective Disorder under Fasting Conditions
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 36
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.Age: 18 - 65 years.
- •2.Sex: Males or non-pregnant, non-lactating females.
- •3.Diagnosed with Schizophrenia or schizoaffective disorder according to the DSM-IV criteria.
- •4.Currently stable on a regimen consisting of multiples of Clozapine 100 mg twice daily for at least 3 months
- •5.Smoking Status: Non-smokers to moderate-smokers ( < 20 cigarettes per day)
- •6.The patient and LAR must demonstrate adequate decision-making ability to make a choice about participating in this study and provide written informed consent to participate.
- •7.Subjects will be otherwise healthy as determined by the investigator in reference to physical examination, medical history and routine hematologic and biochemical tests.
排除标准
- •1.Institutionalized subjects
- •2.Social Habits:
- •A history of alcohol or drug dependence by DSM-IV criteria during the 6-month period immediately prior to study entry
- •Ingestion of any alcoholic food or beverages within the 48 hours prior to the initial dose of study medication
- •Positive tests for drug or alcohol abuse at screening or check-in of any period
- •3.Medications
- •Use of any prescription or over-the-counter (OTC) medications including vitamins and herbal products that would be expected to alter Clozapine pharmacokinetics within fourteen (14) days prior to the initial dose of study medication.
- •Use of any hormonal contraceptives or hormone replacement therapy within 2 months prior to study medication dosing.
- •A depot injection or implant of any drug within 2 months prior to administration of study medication.
- •Use of any medication known to induce or inhibit CYP450 enzyme activity within 28 days prior to the initial dose of study medication
- •4.Diseases:
- •History of any significant cardiovascular, hepatic, renal, pulmonary, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal disease, or malignancies, unless deemed not clinically significant by the Principal Investigator or Co-investigator.
- •History of diabetes, severe allergic reaction
- •Acute illness at the time of either the pre-study medical evaluation or dosing.
- •5.History of allergy or adverse reactions to Clozapine or chemically related psychotropic drugs
- •6. Acute psychotic exacerbations within 3 months of start of study.
- •7.History of suicidal thinking, imminent risk of suicide, or a danger to self or others as judged by the investigator.
- •8.Patients with hypomagnesemia (defined as serum magnesium < 0.7 mEq/L), hypokalemia (defined as serum or plasma potassium < 3.5 mM or mEq/L), prolonged QT interval or bradycardia during screening.
- •9.History or known case of Organic Brain Disease.
- •10.History of Clozapine related agranulocytosis.
- •11.Electroconvulsive therapy (ECT) within 30 days prior to dosing.
- •12.Clinically significant blood pressure or heart rate measurements during screening
- •13.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)
- •14.Abnormal ECG: QTc > 450 msec in male subject or QTc > 470 msec in female subjects at screening
- •15. Heart rate less than 50 beats/min
- •16.History of multiple syncopal episodes
- •17.A history of severe hepatic impairment, drug induced leukopenia/neutropenia, congenital prolongation of the QT interval, cardiac arrhythmias, myocardial infarction or unstable heart disease
- •18.Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, or idiopathic Parkinsonâ??s disease
- •19.History of epilepsy or risk for seizures
- •20.A total white blood cell count below 4000/mL or an absolute neutrophil count below 2000/mL
- •21.A history of granulocytopenia or myeloproliferative disorders (drug-induced or idiopathic)
- •22.Concurrent use of antihypertensive medication or any medication that might predispose to orthostatic hypotension
- •23.Concurrent use of other drugs known to suppress bone marrow function
- •24.Expected change
研究者
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