BA/BE study of Clozapine 100 mg tablets in Schizoprenia patients
- Conditions
- Health Condition 1: null- Schizophrenia
- Registration Number
- CTRI/2016/08/007151
- Lead Sponsor
- APL Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 28
1. 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.
2. Patient with Body mass index between 18.5 to 30 kg/m2 (both inclusive) and aged between 18 to 60 years (both inclusive).
3. 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.
4. Patient having adequate hematologic reserve at screening as per principal investigator assessment.
5. Patient having adequate and stable hepatic function and renal function at screening as per principal investigator assessment.
6. 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.
7. Patient and Legally Acceptable Representative had given consent after being advised of the nature and risks of the study.
8. Female patient of childbearing potential must have a negative serum pregnancy test at screening.
9. Patient agreed to use acceptable methods of birth control as directed by study team.
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 less than or equal to 2000 /mm3 or /microliter and WBC count less than or equal to 4000 /mm3 or /microliter.
3. Elderly patient with diagnosed dementia related psychosis.
4. Patient with medical or surgical condition that might interfere with the absorption, metabolism, or excretion of Clozapine or other study medications.
5. Patient with history of granulocytopenia or myeloproliferative disorder, either drug-induced or idiopathic.
6. Patient with history of clinically significant cardiovascular, renal, hepatic, respiratory, endocrine (except noninsulin-dependent diabetes mellitus), or gastrointestinal disease.
7. Patient found to be positive for HIV, HBs (Ag) or HCV.
8. Patient with history of epilepsy or seizures or are comatose or experiencing severe central nervous system depression.
9. Patient is unable to communicate with the investigator.
10. Patients with history of allergic reactions to Clozapine or chemically related psychotropic drugs.
11. Patients having concurrent neurological diagnosis, including mental retardation, severe tardive dyskinesia, or idiopathic Parkinsonâ??s disease.
12. Patients who had undergone electroconvulsive therapy within the past one month.
13. Patient had demonstrated clinically significant homicidal behavior within the past 12 months.
14. Patient had received any investigational drug within the past 90 days.
15. Patient had history of narrow-angle glaucoma.
16. Patient with known history of phenylketonuria.
17. 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)
18. Patient with uncontrolled hypertension as per the discretion of PI
19. Patient is on concurrent use of other drugs known to suppress bone marrow function.
20. Patient had history of multiple syncopal episodes.
21. Patient is smoker and alcoholic.
22. Patient consumed grape fruit (mosumbi/sweet lime) juice within the 48 hours prior to study check-in.
23. Patient had history of difficulty with donating blood or difficulty in accessibility of veins
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUC0-Ï?: Area under the plasma concentration â?? time curve over the steadystate dosing interval. <br/ ><br>Cmax-ss: Maximum concentration over the steady state dosing interval.Timepoint: 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 <br/ ><br>collected within 5 minutes prior to morning dosing and <br/ ><br>0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, <br/ ><br>6.00, 8.00, 10.00 and 12.00 hrs post morning dose
- Secondary Outcome Measures
Name Time Method Cmin-ss, Cavg-ss, Percentage fluctuation, Tmax-ss, Cpd (pre-dose concentration), Safety and tolerabilityTimepoint: 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 <br/ ><br>collected within 5 minutes prior to morning dosing and <br/ ><br>0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, <br/ ><br>6.00, 8.00, 10.00 and 12.00 hrs post morning dose and safety assessment