Health Condition 1: F209- Schizophrenia, unspecified
Conditions
Interventions
Intervention1: Clozapine 100 mg tablet of Prinston Pharmaceutical Inc., USA: Dose: 100 mg
Duration of treatment: 10 days
Control Intervention1: Clozaril® of Novartis Pharmaceuticals Corporation, USA: Dose: 100 mg
Frequency: twice daily
Sponsors
Prinston Pharmaceutical Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. Written informed consent for participation in the study by the patient and Patientâ??s Legally Acceptable Representative (LAR). 2. Patient has a documented clinical diagnosis of schizophrenia according to DSM IV-TR 3. Patients have a diagnosis of treatment-resistant schizophrenia 4. Male or female patients between 18 and 60 years of age 5. Having a Body Mass Index (BMI) between 18 and 30 (both inclusive), calculated as weight in kg / height in m2. 6. Not having any significant diseases or clinically significant abnormal findings except schizophrenia during screening 7. Patients have been on a daily stable dose of 200 mg clozapine formulation 8. Able to comply with study procedures in the opinion of the investigator. 9. Both male and female patients of child bearing potential must be practicing adequate contraception.Female patients of child-bearing potential must not be orlikely to be pregnant or lactating and must have a negative serum pregnancy test at screening and negative urine pregnancy test at randomization.
Exclusion criteria
Exclusion criteria: 1. Patient with known hypersensitivity/ intolerance to clozapine or any other component of the drug. 2. Clinically symptomatic orthostatic hypotension 3. Concurrent use of antihypertensive medication or any medication that might pre-dispose to orthostatic hypotension. 4. Concurrent primary psychiatric or neurological diagnosis (except schizophrenia), including organic mental disorder, severe tardive dyskinesia, or idiopathic Parkinsonâ??s disease. 5. A history of granulocytopenia or myeloproliferative disorders (drug-induced or idiopathic). 6. A medical or surgical condition that might interfere with the absorption, metabolism, or excretion of clozapine. 7. Known case of poor metabolizer individuals with reduced activity of cytochrome P450 enzymes particularly, 1A2, 2D6 and 3A4. 8. Smokers who smoke 10 or more than 10 cigarette/day or inability to abstain from smoking during the study. 9. Positive tests for drug or alcohol abuse 10. A history of alcohol or drug dependence during the 6-month period immediately prior to study entry 11. Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of study medication or during the study. 12. Receipt of an investigational medicinal product or participation in a drug research study within 90 days prior to receiving the first dose of study medication or during the study. 13. A positive hepatitis screen including hepatitis B surface antigen, HCV. 14. Known case of HIV infection. 15. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others. 16. Presence of glaucoma 17. History of clozapine induced agranulocytosis or severe granulocytopenia 18. Patient with hyperprolactinemia 19. Concurrent use of other drugs known to suppress bone marrow function
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Incidence of drug related Adverse Events as assessed by clinical examination, vitals and/or laboratory parameters for both the treatmentsTimepoint: Day 1 to Day 20 | — |
Primary
| Measure | Time frame |
|---|---|
| Cmax,ss and AUC0-T,ssTimepoint: Day 10 and Day 20 | — |
Countries
India
Contacts
Public ContactDr Kaksha Patel
Lambda Therapeutic Research Ltd
Outcome results
None listed