A Clinical Trial to study the clinical bioequivalence of Clozapine 100 mg tablet of Aurobindo in comparison to Clozaril® (Clozapine) 100 mg tablet of Novartis in patients suffering from Schizophrenia
- Conditions
- Health Condition 1: null- Schizophrenia
- Registration Number
- CTRI/2013/06/003745
- Lead Sponsor
- Aurobindo Pharma Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
1)Patients have a diagnosis of 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, Fourth Edition (DSM-IV) criteria
2)Body mass index between 18 and 35kg/m2 aged between 18 and 60 years
3)Patients should be appropriate candidates for Clozapine therapy (as stated in product labeling) and have been taking a stable dose of Clozapine for at least three months.
4) Patients who are already receiving/ stabilized on Clozapine daily dose of 100mg twice daily (100 mg Q12h).
5)Patients should be otherwise healthy as determined by physical examination, medical history, and no significant abnormality in any of the laboratory parameters including ECG and Chest X-ray.
6)Ability to comprehend the full nature and purpose of the study, including possible risks and adverse events; ability to co-operate with the Investigator and to comply with the requirements of the entire study.
7)Patients/Legal Representative has given written consent after being advised of the nature and risks of the study.
8)Patients must have adequate hematologic reserve
I.Hemoglobin >=10gm/dL
II.WBC (white blood cells) >4000/mm3
III.Platelets >=100,000/mm3
IV.ANC (absolute neutrophils count) >2000/mm3
9) Adequate and stable hepatic function at screening as defined by:
I.Bilirubin <1.5 X ULN (upper limit of normal)
II.AST/ ALT <1.5 X ULN
III.Total Triglycerides <1.5 X ULN
IV.Total Cholesterol <1.5 X ULN
10) Adequate renal function at screening as defined by:
I.Creatinine <1.5 X ULN for the clinical laboratory
11) Female subjects of childbearing potential must have a negative serum pregnancy test at enrolment
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 and WBC count <= 4000/mm3.
3)Elderly patients with diagonosed dementia related psychosis.
4)Patients have a medical or surgical condition that might interfere with the absorption, metabolism, or excretion of Clozapine or other study medications.
5)Patients have a history of granulocytopenia or myeloproliferative disorder, either drug-induced or idiopathic.
6)Patients have a history of clinically significant cardiovascular, renal, hepatic,respiratory, endocrine (except noninsulin-dependent diabetes mellitus), or gastrointestinal disease.
7)Patients have a known history of human immunodeficiency virus infection.
8)Patients have a history of epilepsy or seizures or are comatose or experiencing severe central nervous system depression.
9)Patients are unable to communicate with the investigator.
10)Patients have a history of allergic reactions to Clozapine or chemically related psychotropic drugs.
11)Patients have a concurrent primary psychiatric or neurological diagnosis, including organic mental disorder (DSM-IV criteria), mental retardation, severe tardive dyskinesia, or idiopathic Parkinsonâ??s disease.
12)Patients have had electroconvulsive therapy within the past one month.
13)Patients have demonstrated clinically significant homicidal behavior within the past 12 months.
14) Patients have received an investigational drug within the past 90 days.
15) Patients have a history of narrow-angle glaucoma.
16) Patients require 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.
17) Patients have a known history of phenylketonuria.
18) 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)
19) Concurrent use of antihypertensive medication or any medication that might predispose to orthostatic hypotension.
20)Concurrent use of other drugs known to suppress bone marrow function.
21)Positive tests for drug or alcohol abuse at screening or baseline.
22)A history of alcohol or drug dependence by Diagnostic and statistical manual of Mental Disorders IV (DSM-IV) criteria during the 6-month period immediately prior to study entry.
23)History of multiple syncopal episodes.
24)Patients who smokes.
25)Expected changes in concomitant medication during the period of study
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method