Health Condition 1: null- Schizophrenia
Conditions
Interventions
Intervention1: Clozapine Tablets USP 100 mg of Micro Labs Limited, India.: As per randomization schedule, subjects will be instructed to receive test or reference products according to their stabilize
Manufactured by - Novartis Pharma Corp., Suffern, NY 10901
Distributed by - Novartis Pharma Corp., East Hanover, NJ 07936.: As per randomization schedule, subjects will be instructed to receive test or reference products according to their stabilized dose of
Sponsors
Micro Labs Limited India
Eligibility
Inclusion criteria
Inclusion criteria: A subject fulfilling all the following criteria will be included in the present study: 1. Subjects and his/her legally acceptable representatives (LAR) â?? a. Willing to provide written informed consent for participation in the study; b. Having ability to comprehend the nature and purpose of the study; c. Willing to be available for the entire study period and to comply protocol requirements. 2. Disease population and treatment condition â?? a. Subjects with documented clinical diagnosis of Schizophrenia as per DSM-IV-TR Criteria; b. Subjects with Treatment-resistant Schizophrenia defined as failure to respond to two or more antipsychotic medications given in therapeutic dose for >= six weeks); c. Currently stable on a regimen consisting of single or multiples of Clozapine tablets 100mg twice daily for at least 3 months. 3. Age of 18-65 years (both inclusive); 4. Body mass index (BMI) in the range of 18.50 â?? 29.99 kg/m2 (both inclusive); 5. Non-smoker and willing to abstain from chewing any tobacco containing product during housing period in clinical facility; 6. Willing to abstain from alcohol or alcoholic products, xanthine or its derivative containing food or beverages (e.g. chocolates, tea, coffee or cola drinks), and grapefruit or its juice during housing period in clinical facility; 7. Adequate hematological reserves, particularly â?? a. A total WBC count >= 4000/µL; b. ANC >=2000/mL; 8. Clinically non-significant serum electrolytes (sodium, potassium, magnesium and chloride); 9. With normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis; 10. With a normal or clinically non-significant 12-lead ECG (including QTc interval 11. In case of female subjects: a. Negative urine pregnancy test during screening and, negative serum β-HCG test at baseline visits and at check-in for housing during each study period; b. Female subjects with child bearing potential or those within their first two years of onset of menopausal syndrome must either abstain from sexual intercourse, or using acceptable methods of birth control during the study (Acceptable birth control methods include barrier methods such as diaphragm/condom with spermicide or who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed).
Exclusion criteria
Exclusion criteria: A subject fulfilling any one of the following criteria will be excluded from the study: 1. Institutionalized subjects; 2. A history of allergic or hypersensitive reactions to clozapine or other chemically related psychotropic drugs or to any of the excipients of formulation which in the opinion of an investigator, would compromise the safety of the subject or the study; 3. Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, or idiopathic Parkinsonâ??s disease; 4. Acute psychotic exacerbations within 3 months of start of study; 5. Elder subjects with dementia-related psychosis; 6. History of suicidal thinking, imminent risk of suicide, or a danger to self or others as judged by the investigator; 7. A history of granulocytopenia or myeloproliferative disorders (drug-induced or idiopathic); 8. Concurrent use of other drugs known to suppress bone marrow function; 9. 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); 10. History of multiple syncopal episodes; 11. Concurrent use of antihypertensive medication or any medication that might pre¬dispose to orthostatic hypotension; 12. A medical or surgical condition that might interfere with the absorption, metabolism, or excretion of clozapine; 13. A history of epilepsy or risk for seizures; 14. Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, immunological or psychiatric diseases, or organ dysfunction, which in the opinion of an investigator, would compromise the safety of the subject or the study; 15. Expected changes in concomitant medications during the study periods; 16. Expected incompliance with outpatient medications; 17. A history of alcohol or drug dependence by DSM-IV-TR criteria during the 6-month period immediately prior to study entry; 18. Positive alcohol breath or urine drug of abuse tests during baseline visits, or at check-in for housing during each study period; 19. Positive test for Human Immunovirus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus (HCV) antibodies; 20. In case of female subjects: a. Planning to become pregnant; b. Lactating or nursing subjects; c. Using hormonal contraceptive (either oral/implants); 21. Participated in any clinical investigation requiring repeated blood sampling, blood donation, or have blood loss of >500 mL in past 8 weeks or participated in any clinical study within the past 3 months prior to first dosing of the study; 22. Any major illness or hospitalization within 90 days prior to first dosing of the study; 23. History of difficulty in accessibility of veins in arms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to assess whether the test product is bioequivalent to reference product based on the evaluation of Cmax,ss and AUC0-Ï?,ss.Timepoint: During each study period, pre-dose samples will be collected on days - 7,8,9 and 10 for morning dose. On day 10 of each study period, post-dose samples will be collected at 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00 and 12.00 hours post morning dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of safety and tolerability profile of test and reference products.Timepoint: During the study;Descriptive statistics for PK parameters - Cmin,ss, Cavg,ss Degree of Fluctuation, Swing, Cpd and Tmax,ss;Timepoint: During each study period, pre-dose samples will be collected on days - 7,8,9 and 10 for morning dose. On day 10 of each study period, post-dose samples will be collected at 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00 and 12.00 hours post morning dose. | — |
Countries
India
Contacts
Public ContactDr Himali Gole
Raptim Research Ltd.
Outcome results
None listed