CTRI/2016/08/007151尚未招募不适用
A Multicentric, Open Label, Randomized, Two-Treatment, Two-sequence, Two-period, Cross-over, Steady-state Clinical Bioequivalence Study of Clozapine 100 mg Tablets of Aurobindo Pharma Limited, India (Test) with Leponex (Clozapine) 100 mg tablets of Novartis Pharma GmbH 90327 Nürnberg (Reference) in Schizophrenic Patients Already Receiving/ Stabilized With Clozapine Under Fasting Conditions.
APL Research Center2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2016年8月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- AUC0-τ: Area under the plasma concentration – time curve over the steadystate dosing interval.
研究概览
简要总结
This is a multicentric, open-label, randomized, two-treatment, two-sequence, two-period, cross-over, steady-state clinical bioequivalence study of Clozapine 100 mg Tablets of Aurobindo Pharma Limited, India (Test) with Leponex (Clozapine) 100 mg tablets of Novartis Pharma GmbH 90327 Nürnberg (Reference) in schizophrenic patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
- •Patient with Body mass index between 18.5 to 30 kg/m2 (both inclusive) and aged between 18 to 60 years (both inclusive).
- •Patient is on for Clozapine therapy and has been taking a stable dose of Clozapine 100 mg twice daily for at least three months before enrolment in the study.
- •Patient having adequate hematologic reserve at screening as per principal investigator assessment.
- •Patient having adequate and stable hepatic function and renal function at screening as per principal investigator assessment.
- •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.
- •Patient and Legally Acceptable Representative had given consent after being advised of the nature and risks of the study.
- •Female patient of childbearing potential must have a negative serum pregnancy test at screening.
- •Patient agreed to use acceptable methods of birth control as directed by study team.
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.
- •Absolute neutrophil count less than or equal to 2000 /mm3 or /microliter and WBC count less than or equal to 4000 /mm3 or /microliter.
- •Elderly patient with diagnosed dementia related psychosis.
- •Patient with medical or surgical condition that might interfere with the absorption, metabolism, or excretion of Clozapine or other study medications.
- •Patient with history of granulocytopenia or myeloproliferative disorder, either drug-induced or idiopathic.
- •Patient with history of clinically significant cardiovascular, renal, hepatic, respiratory, endocrine (except noninsulin-dependent diabetes mellitus), or gastrointestinal disease.
- •Patient found to be positive for HIV, HBs (Ag) or HCV.
- •Patient with history of epilepsy or seizures or are comatose or experiencing severe central nervous system depression.
- •Patient is unable to communicate with the investigator.
- •Patients with history of allergic reactions to Clozapine or chemically related psychotropic drugs.
- •Patients having concurrent neurological diagnosis, including mental retardation, severe tardive dyskinesia, or idiopathic Parkinson’s disease.
- •Patients who had undergone electroconvulsive therapy within the past one month.
- •Patient had demonstrated clinically significant homicidal behavior within the past 12 months.
- •Patient had received any investigational drug within the past 90 days.
- •Patient had history of narrow-angle glaucoma.
- •Patient 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)
- •Patient is on concurrent use of other drugs known to suppress bone marrow function.
- •Patient had history of multiple syncopal episodes.
- •Patient is smoker and alcoholic.
- •Patient consumed grape fruit (mosumbi/sweet lime) juice within the 48 hours prior to study check-in.
- •Patient had history of difficulty with donating blood or difficulty in accessibility of veins.
结局指标
主要结局
AUC0-τ: Area under the plasma concentration – time curve over the steadystate dosing interval.
时间窗: Predose will be collected within 5 minutes prior to dosing on Day 7 8 and 9 in Period I Day 17 18 and 19 in Period II. On Day 10 and Day 20, pre dose sample will be | collected within 5 minutes prior to morning dosing and | 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, | 6.00, 8.00, 10.00 and 12.00 hrs post morning dose
Cmax-ss: Maximum concentration over the steady state dosing interval.
时间窗: Predose will be collected within 5 minutes prior to dosing on Day 7 8 and 9 in Period I Day 17 18 and 19 in Period II. On Day 10 and Day 20, pre dose sample will be | collected within 5 minutes prior to morning dosing and | 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, | 6.00, 8.00, 10.00 and 12.00 hrs post morning dose
次要结局
- Cmin-ss, Cavg-ss, Percentage fluctuation, Tmax-ss, Cpd (pre-dose concentration), Safety and tolerability(Predose will be collected within 5 minutes prior to dosing on Day 7 8 and 9 in Period I Day 17 18 and 19 in Period II. On Day 10 and Day 20, pre dose sample will be)
研究者
研究点 (2)
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