Health Condition 1: F20- Schizophrenia
Conditions
Interventions
Intervention1: Clozapine Tablets USP 100 mg of Micro Labs Limited, India: In period-I (from day 1 to day 10), patients will receive either the Test product or the reference product every 12 hours for
Sponsors
Micro Labs Limited, India
Eligibility
Inclusion criteria
Inclusion criteria: Patient fulfilling all the following criteria will be included in the study: 1.Patient and his/her legally acceptable representative (LAR): 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 comply with protocol requirements. 2. Disease population: a. Patients with documented clinical diagnosis of Schizophrenia as per Diagnostic and Statistical Manual of Mental Disorders (DSM-V Criteria); 3. Treatment condition: a. Patients with treatment-resistant Schizophrenia defined as failure to respond to two or more antipsychotic medications given in therapeutic dose for = six weeks); b. Currently stable on a regimen consisting of single or multiples of Clozapine tablets 100 mg twice daily (up to a maximum daily dose of 400 mg) for at least 3 months prior to randomization. 4. Patient should be otherwise healthy as determined by physical examination, medical history, and routine hematologic and biochemical tests; 5. Age of 18-65 years (both inclusive); 6. Body mass index (BMI) in the range of 18.50 – 29.99 kg/m2 (both inclusive); 7. HbA1c 8. Non-smoker and willing to abstain from chewing any tobacco containing product during housing period in clinical facility; 9. 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; 10. Adequate hematological reserves, particularly: a. A total white blood cells (WBC) count = 3500 /µL; b. Absolute neutrophil count (ANC) =2000/µL; 11. Clinically non-significant serum electrolytes (sodium, potassium, magnesium and chloride); 12. With normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis; 13. With a normal or clinically non-significant 12-lead ECG; 14. In case of female patients: a. Negative urine pregnancy test during screening and, negative serum ß-hCG test at baseline visit and at check-in for housing during each study period; b. Female patient 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: 1. Patient fulfilling any one of the following criteria will be excluded from the study: A. Institutionalized patients; B. A history of allergic or hypersensitive reactions to 2. Clozapine or other chemically related psychotropic drugs or to any of the excipients of formulation which in the opinion of investigator, would compromise the safety of the patient or the study; 3. Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, or idiopathic Parkinson?s disease; 4. Acute psychotic exacerbations within 3 months of start of study; 5. Elder patients 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. History of syncope or 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); 10. Concurrent use of antihypertensive medication or any medication that might predispose to orthostatic hypotension; 11. A medical or surgical condition that might interfere with the absorption, metabolism, or excretion of Clozapine; 12. A history of epilepsy or risk for seizures; 13. 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 patient or the study; 14. Patients with a current diagnosis or prior history of constipation; 15 .Expected changes in concomitant medications (including inhibitors or inducers of CYP3A4 or CYP1A2) during the study periods;Expected incompliance with outpatient medications; 16. A history of alcohol or drug dependence by DSM-V criteria during the 6-month period immediately prior to study entry; 17. Positive urine alcohol or urine drug of abuse tests during baseline visits, or at each check-in for housing during each study period; 18. Positive test for Human Immunovirus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus (HCV) antibodies; 19. In case of female patients: a. Planning to become pregnant; b. Lactating or nursing patients; c. Using hormonal contraceptive (either oral/implants); 20Participated in any clinical investigation requiring repeated blood sampling or have donated blood in past 90 days prior to first dosing; 21. Any major illness or hospitalization within 90 days prior to first dosing of the study; a. History of Phenylketonuria; b. History of Glaucoma; c. History of difficulty in accessibility of veins in arms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess bioequivalence of the test product in comparison with the reference product.Timepoint: Pre-dose (within 5 minutes of scheduled morning dosing time), and 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 |
|---|---|
| To assess safety and tolerability profile of test and reference productsTimepoint: Post-study safety evaluations will be performed at the time of period-II checkout (on Day 21) but before taking any medication as per the standard of care. | — |
Countries
India
Contacts
Public ContactDinesh Kumar Garg
Raptim Research Private Ltd.
Outcome results
None listed