CTRI/2018/02/012062已完成未知
A Randomized, Open-Label, Two Period, Two-Treatment, Two Sequence,Crossover, Multiple-Dose, Steady State, Multicentre, Bioequivalence Studyof Two Formulations of Clozapine Tablets USP 100 mg in Patients withSchizophrenia or Schizoaffective Disorder under Fasting Conditions.
Alembic Pharmaceuticals Limited India0 个研究点目标入组 40 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
- 40
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
- •Sex: Males or non-pregnant, non-lactating females.
- •- In case of females of child bearing potential, a negative pregnancy test is required
- •to participate in the study.
- •- Acceptable forms of contraception include the following:
- •a. Taking oral contraceptives or Intrauterine device in place for at least 2
- •months prior to the start of the study and remaining in place during the
- •study period, or
- •b. Barrier methods containing or used in conjunction with a spermicidal
- •c. Surgical sterilization, or
- •d. Practicing sexual abstinence throughout the course of the study
- •- Females will not be considered of childbearing potential if one of the following is
- •reported and documented on the medical history:
- •a. spontaneous amenorrhea for at least one year, or
- •b. 6 months of spontaneous amenorrhea with serum FSH levels > 40
- •c. at least 6 weeks postsurgical following bilateral oophorectomy with or
- •without hysterectomy
- •- Diagnosed with Schizophrenia or schizoaffective disorder according to the DSM-V
- •-All patients should have a Body Mass Index (BMI) less than or equal to 35 but greater than
- •or equal to 18. BMI values should be rounded to the nearest integer. (e.g. 35.4 rounds
- •down to 35.
- •- Currently stable on a regimen consisting of multiples of Clozapine 100 mg twice daily for
- •at least 3 months
- •- Smoking Status: Non-smokers
- •- 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.
排除标准
- •Patients must not be enrolled in the study if they meet any one of the following criteria:
- •1) Institutionalized subjects
- •2) Social Habits:
- •- A history of alcohol or drug dependence by DSM-V 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
- •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 anticholinergic medications
- •- Use of any medication known to induce or inhibit CYP450 enzyme activity (CYP1A2,
- •CYP 3A and CYP2D6) within 28 days prior to the initial dose of study medication
- •(Refer Appendix II).
- •4) Diseases:
- •- History of or presence of 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.
- •PROTOCOL # CRL061516
- •Protocol Version 3.0 dated 05 May 2017 Confidential Page 27 of 67
- •- 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
- •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, hypokalemia, prolonged QT interval, abnormal ECG 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) Abnormal blood pressure (systolic BP <100 mm Hg or >=140 mm Hg, diastolic BP <60
- •mm Hg or >=90 mm Hg) or heart rate ( <60 bpm or >100 bpm) measurements during
- •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) History of multiple syncopal episodes
- •15) A history of severe hepatic impairment, drug induced leukopenia/neutropenia, congenital
- •prolongation of the QT interval, cardiac arrhythmias, myocardial infarction or unstable
- •heart disease
- •16) Concurrent primary psychiatric or neurological diagnosis, including organic mental
- •disorder, severe tardive dyskinesia, or idiopathic Parkinsonâ??s disease
- •17) History of epilepsy or risk for seizures
- •18) A total white blood cell count below 4000/mL or an absolute neutrophil count below
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研究者
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