Health Condition 1: null- Schizophrenia
Conditions
Interventions
Intervention1: Clozapine 300 mg tablets: Clozapine 300 mg sustained release tablets [OD] of JSC â??Valenta Pharmâ?? Russia
Route of admin: Oral
Duration of therapy 20 days (Ten days in each arm)
Con
Sponsors
JSC Valenta Pharm
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients willing to participate by providing written informed consent. 2.Schizophrenic patients aged between 18 to 60 [both inclusive] with a documented clinical diagnosis of schizophrenia according to DSM IV-TR and who are receiving a stable thrice daily dose of Clozapine 100 mg tablet for at least three months. 3.Patient having a Body Mass Index (BMI) between 18.00 and 30.00 kg/m2 (Both inclusive), 4.Except Schizophrenia otherwise patients should be healthy as determined by physical examination, medical history, and routine hematologic and biochemical tests. 5.Patient must be agreeing to - use effective method of contraception while on treatment and for three months after completion of therapy 6.Able to comply with study procedures in the opinion of the investigator.
Exclusion criteria
Exclusion criteria: 1.History of allergic reactions to clozapine or other chemically related psychotropic drugs. 2.Medical history of clinically significant cardiovascular, renal, hepatic, gastrointestinal disease or blood disorders. 3.Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, or idiopathic Parkinsonâ??s disease. 4.Patient with history of use of antichloinergic drugs and pateint with history of narrow angle glaucoma. 5.HIV, HCV, HBsAg positive. 6.Total white blood cell count below 4000/mL, or an absolute neutrophil count below 2000/mL. 7.History of granulocytopenia or myeloproliferative disorders (drug-induced or idiopathic) 8.Significant orthostatic hypotension (i.e., a drop in systolic blood pressure of 20 mm Hg or more and/or a drop in diastolic blood pressure of 10 mm Hg or more on standing). 9.Concurrent use of antihypertensive medication or any medication that might pre¬dispose to orthostatic hypotension. 10.Medical or surgical condition that might interfere with the absorption, metabolism, or excretion of clozapine. 11.History of epilepsy or risk for seizures. 12.Concurrent use of other drugs known to suppress bone marrow function. 13.Expected changes in concomitant medications during the period of study. 14.Positive tests for drug or alcohol abuse at screening or baseline. 15.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. 16.Patient unable to comply with the study procedures 17.History of multiple syncopal episodes. 18.Pregnant or lactating females 19.History of significant blood loss due to any reason in the past 3 months. 20.Any pre-existing bleeding disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the oral bioavailability of Clozapine 300 mg sustained release tablets of JSC â??Valenta Pharmâ??, Russia versus LEPONEX® (Clozapine) 100 mg tablets [TID] of Novartis Pharmaceuticals Ltd.,UK,Timepoint: Two periods of 10 days each. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the adverse events and to ensure the safety of the patientsTimepoint: entire study period | — |
Countries
India
Contacts
Public ContactDr Anand Eswaraiah MD
Syngene International Limited
Outcome results
None listed