Health Condition 1: F20- Schizophrenia
Conditions
Interventions
Intervention1: ZIPROC-100 (Clozapine) 100 mg Tablets of Torrent Pharma Philippines Inc., Philippines: Clozapine 100 mg tablets will be administered twice daily orally (every12-hours) with 240 mL of wa
Sponsors
Torrent Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: • Patients of either sex, aged 18 to 55 years (both inclusive) having clinical diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria (DSM-V TR) • Patients with body mass index between 18 and 25 kg/m2 • Patients who are appropriate candidates for Clozapine therapy (as stated in ZIPROC-100 and LEPONEX® package inserts) and have been taking a stable dose of Clozapine 100 mg twice daily for at least three months before enrolment in the study • Patients who are healthy as determined by physical examination, medical history, and no significant abnormality in any of the laboratory parameters, including electrocardiogram and Chest x-ray • Ability to comprehend the full nature and purpose of the study, including possible risks and adverse events (AEs); ability to co-operate with the investigator and study team and to comply with the requirements of the entire study • Patients/legally acceptable representative has given written consent after being advised of the nature and risks of the study • Patients must have adequate hematologic reserve: Hemoglobin (Hb) >= 11 gm/dL White blood cells (WBC) >= 4000 /mm3 or /μL Platelets >= 100,000 mm3 or /μL Absolute neutrophil count (ANC) >= 2000 /mm3 or /μL • Adequate and stable hepatic function at screening as defined by: Bilirubin Aspartate aminotransferase/alanine aminotransferase (AST/ ALT) Total triglycerides Total cholesterol • Adequate renal function at screening as defined by: Creatinine Serum potassium Serum magnesium • Female patients of childbearing potential must have a negative urine pregnancy test at screening and check-in
Exclusion criteria
Exclusion criteria: • 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 • Elderly patients with diagnosed dementia related psychosis • Patients with medical or surgical condition that might interfere with the absorption, metabolism, or excretion of Clozapine or other study medications • Patients with history of granulocytopenia or myeloproliferative disorder, either drug-induced or idiopathic • Patients with history of clinically significant cardiovascular, renal, hepatic, respiratory, endocrine (except noninsulin-dependent diabetes mellitus), or gastrointestinal disease • Patientâ??s positive for HIV, HBs Ag or HCV • Patients with history of epilepsy or seizures or are comatose or experiencing severe central nervous system depression • Patients who are unable to communicate with the investigator and study team • Patients with a history of allergic reactions to Clozapine or chemically related psychotropic drugs • Patients having concurrent primary psychiatric or neurological diagnosis, including organic mental disorder (DSM-V criteria), mental retardation, severe tardive dyskinesia, or idiopathic Parkinsonâ??s disease • Patients who had undergone electroconvulsive therapy within the past 1 month • Patients have demonstrated clinically significant homicidal behaviour within the past 12 months • Patients have received any investigational drug within the past 90 days • Patients having a history of narrow-angle glaucoma • Patients requiring 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 • Patients 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) • Concurrent use of antihypertensive medication or any medication that might pre-dispose to orthostatic hypotension • Positive tests for drug or alcohol abuse at screening and before check-in • A history of alcohol or drug dependence by DSM-V criteria during the 6-month period immediately prior to study entry • History of multiple syncopal episodes • Patients who smoke more than 10 cigarettes / day or unable to abstain from smoking during the study • Expected changes in concomitant medication during the period of study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ AUC0-tau ss: Area under the plasma concentration â?? time curve over the steady state dosing interval â?¢ Cmax ss: Maximum concentration over the steady state dosing interval Timepoint: On Day 10 and Day 20 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Cmin ss: Minimum concentration over the steady state dosing interval â?¢ Cavg ss: Average concentration over the steady state dosing interval â?¢ Tmax ss: Time of maximum measured plasma concentration over the steady state dosing interval â?¢ Percentage fluctuation: [100 Ã? (Cmax ss - Cmin ss)/Cavg ss] â?¢ Swing [Cmax ss â?? C min ss/Cmin ss] Ã? 100 â?¢ Cpd (pre-dose concentration)-Pre-dose concentrations determined before a dose at steady stateTimepoint: Cmin ss, Cavg ss, Tmax ss, Percentage fluctuation, Swing on Day 10 and Day 20 Cpd (pre-dose concentration) on Day 7 to Day 10; Day 17 to Day 20 | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
JSS Medical Research India Limited
Outcome results
None listed