Health Condition 1: null- Schizophrenia or Schizoaffective Disorder
Conditions
Interventions
Intervention1: Clozapine: Clozapine
(100 mg or multiples of 100mg) will be administered in the morning and evening i.e. twice daily as per the
randomization schedule daily from day 01 to day 10 in ea
Sponsors
Cadila healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: 18 - 65 years. 2. Sex: Males or non-pregnant, non-lactating females. 3. Diagnosed with Schizophrenia or schizoaffective disorder according to the DSM-IV criteria. 4. Currently stable on a regimen consisting of multiples of Clozapine 100 mg twice daily for at least 3 months 5. Smoking Status: Non-smokers to moderate-smokers ( 6. The patient and LAR must demonstrate adequate decision-making ability to make a choice about participating in this study and provide written informed consent to participate. 7. Subjects will be otherwise healthy as determined by the investigator in reference to physical examination, medical history and routine hematologic and biochemical tests.
Exclusion criteria
Exclusion criteria: 1. Institutionalized subjects 2. Social Habits: A history of alcohol or drug dependence by DSM-IV criteria during the 6-month period immediately prior to study entry Ingestion of any alcoholic food or beverages within the 48 hours prior to the initial dose of study medication Positive tests for drug or alcohol abuse at screening or check-in of any period 3. Medications Use of any prescription or over-the-counter (OTC) medications including vitamins and herbal products that would be expected to alter Clozapine pharmacokinetics within fourteen (14) days prior to the initial dose of study medication. Use of any hormonal contraceptives or hormone replacement therapy within 2 months prior to study medication dosing. A depot injection or implant of any drug within 2 months prior to administration of study medication. Use of any medication known to induce or inhibit CYP450 enzyme activity within 28 days prior to the initial dose of study medication 4. Diseases: History of any significant cardiovascular, hepatic, renal, pulmonary, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal disease, or malignancies, unless deemed not clinically significant by the Principal Investigator or Co-investigator. History of diabetes, severe allergic reaction Acute illness at the time of either the pre-study medical evaluation or dosing. 5. History of allergy or adverse reactions to Clozapine or chemically related psychotropic drugs 6. Acute psychotic exacerbations within 3 months of start of study. 7. History of suicidal thinking, imminent risk of suicide, or a danger to self or others as judged by the investigator. 8. Patients with hypomagnesemia (defined as serum magnesium 9. History or known case of Organic Brain Disease. 10. History of Clozapine related agranulocytosis. 11. Electroconvulsive therapy (ECT) within 30 days prior to dosing. 12. Clinically significant blood pressure or heart rate measurements during screening 13. 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) 14. Abnormal ECG: QTc > 450 msec in male subject or QTc > 470 msec in female subjects at screening 15. Heart rate less than 50 beats/min 16. History of multiple syncopal episodes 17. A history of severe hepatic impairment, drug induced leukopenia/neutropenia, congenital prolongation of the QT interval, cardiac arrhythmias, myocardial infarction or unstable heart disease 18. Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, or idiopathic Parkinsonâ??s disease 19. History of epilepsy or risk for seizures 20. A total white blood cell count below 4000/mL or an absolute neutrophil count below 2000/mL 21. A history of granulocytopenia or myeloproliferative disorders (drug-induced or idiopathic) 22. Concurrent use of antihypertensive medication or any medication that might predispose to orthostatic hypotension 23. Concurrent use of other drugs known to suppress bone marrow function 24. Expected change
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the PK profile of Clozapinr and ClozarilTimepoint: Day1- pre-dose sample in each period. Day 07 to Day 10, a pre-dose Day 10, at 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0,10.0, 12.0 hours post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparision the safety profile of Clozapine and ClozarilTimepoint: â?¢ The blood pressure, heart rate, respiratory rate and body temperature will be measured prior to dosing (within 120 minutes prior to dosing) on Days 01, 07, 08, 09 and 10 in each period. â?¢ The blood pressure, respiratory rate and heart rate will be measured at 1, 4 & 8 hours (± 30 minutes) post dose on Day 01 in each period. â?¢ The blood pressure, respiratory rate and heart rate will be measured at 1, 2, 4, 6 & 12 hours (± 30 minutes) post dose on Day 10 in each period | — |
Countries
India
Contacts
Public ContactDr Chirag Shah
Cliantha Research Ltd.
Outcome results
None listed