Health Condition 1: F20- Schizophrenia
Conditions
Interventions
Intervention1: Clozapine Tablets USP 100 mg: Dose: 100 mg, Duration: 10 days Frequency of Administration: Twice a day, Route of Administration: Oral
Control Intervention1: CLOZARIL (Clozapine) Tabl
Sponsors
Mankind Pharma Ltd
Cliantha Research limited
Eligibility
Inclusion criteria
Inclusion criteria: Participant will be eligible for inclusion in this study only if all of the following criteria apply: 1) Male or non-pregnant, non-lactating female participant aged between 18 to 60 years (both inclusive). 2) Participant who is diagnosed with schizophrenia, according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) or latest version criteria. 3) Schizophrenic participant who are on stable dose of clozapine for at least 3 months prior to randomization and receiving clozapine in multiples of 100 mg every 12 hours. 4) Participant have a diagnosis of treatment-resistant schizophrenia. Note: Treatment resistance schizophrenia is defined as a lack of satisfactory clinical improvement despite the use of adequate doses of at least two different antipsychotic agents, including an atypical antipsychotic agent, prescribed for adequate duration. (at least 15 days for each antipsychotic agent), or have severe, untreatable neurological adverse reactions to other antipsychotic agents, including atypical antipsychotics. 5) Participant with Body mass index between 18.5 to 30.0 kg/m2 (both inclusive). 6) Participant having adequate hematologic functions at screening: a. Absolute neutrophil count Greater than or Equal to 2000 /microL b. WBC count Greater than or Equal to 4000 /microL c. Platelet count Greater than or Equal to 100,000 /microL 7) Participant having adequate and stable hepatic function, lipid profile and renal function at screening: a. Bilirubin Less than or Equal to 1.5 X ULN (Upper limit of normal) b. AST/ALT Less than or Equal to 1.5 X ULN c. Total Triglyceride Less than or Equal to 1.5 X ULN d. Total cholesterol Less than or Equal to 1.5 X ULN e. Creatinine Less than or Equal to 1.5 X ULN 8) Non-smoker (i.e., having no past history of smoking for at least one year prior to screening). 9) Male participant if sexually active with a female of child bearing potential must agree to use barrier method of contraception throughout the study period and for at least 3 months after last dose of study IPs. 10) Female participant with postmenopausal status or female of childbearing potential with negative pregnancy test must agree to practice an acceptable method of contraception throughout the study period and for at least 6 months after last dose of IPs. Postmenopausal is defined by any one of the following: a. Postmenopausal with spontaneous amenorrhea for at least one year, or b. 6 months to 12 months of spontaneous amenorrhea with serum FSH levels Greater than 40 mIU/mL, or c. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or d. Total hysterectomy and an absence of bleeding for at least 3 months. 11) Participant willing and able to comply with the protocol requirements. 12) Participant/LAR willing to provide informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: Participant will not be eligible for inclusion in this study if any of the following criteria apply: 1) History of suicidal tendencies (e.g. suicidal attempts) or immediate risk of harm to self or others within the past 3 months prior to screening, as judged by the investigator. 2) Participant diagnosed with dementia related psychosis. 3) Participant with medical or surgical condition that might interfere with the absorption, metabolism, or excretion of Clozapine or other study medications. 4) Participant with any significant disease or condition which might compromise the hemopoietic, gastrointestinal (e.g., pancreatitis), renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis, or any other body system. 5) Participant with hypomagnesemia [defined as serum magnesium Less than Lower limit of normal (LLN)], hypokalemia (defined as serum or plasma potassium Less than LLN) at screening visit. 6) Participant with history of granulocytopenia or myeloproliferative disorder, either drug induced or idiopathic. 7) Participant with history of Neuroleptic Malignant Syndrome. 8) Participant with history of any significant disease or condition related to cardiovascular system like myocarditis, pericarditis, cardiomyopathy and mitral valve. 9) History of uncontrolled diabetes (HbA1c Greater than 10 percent), severe allergic reaction. 10) Participant with history of epilepsy or seizures or is comatose or experiencing severe central nervous system depression. 11) Participant with history of allergic reactions to Clozapine or chemically related psychotropic drugs 12) History of an inherited hyperlipidemia or metabolic syndrome. 13) Participant had history of narrow-angle glaucoma. 14) Participant had history of multiple syncopal episodes. 15) Known history of being a poor CYP2D6 metabolizer. 16) Participant with serum positivity for Hepatitis B, C, or HIV at screening visit. 17) Acute psychotic exacerbations within 3 months prior to screening visit. 18) Participant having concurrent neurological diagnosis, including mental retardation, severe tardive dyskinesia, or idiopathic Parkinson s disease. 19) QTc (Heart Rate Corrected QT interval) Greater than 450 msec (male) or Greater than 470 msec (female) or family history of long QT syndrome. QT interval will be calculated with Bazett s Formula at screening visit. 20) Participant who had undergone electroconvulsive therapy within 3 months prior to screening visit. 21) Participant had demonstrated clinically significant homicidal behavior within 1 year prior to screening visit. 22) Participation in any investigational drug study within 30 days prior to screening visit. 23) 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) at screening visit. 24) Concurrent use of antihypertensive medication or any medication that might predispose to orthostatic hypotension. 25) Substance abuse or alcohol dependence during the 6-month period immediately prior to screening visit (except dependence in full remission). 26) Use of any medication known to induce or inhibit CYP450 enzyme activity (CYP1A2, CYP3A4 and CYP2D6) within 28 days prior to randomization (Refer Appendix III). 27) Partici
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare and access the bioequivalence between Clozapine Tablets USP 100 mg of Mankind Pharma Ltd, India with CLOZARIL (Clozapine) Tablets 100 mg of HLS Therapeutics (USA), Inc. Rosemont, PA 19010 in adult participants with schizophrenia receiving stable dose of Clozapine under fasting condition.Timepoint: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of participants.Timepoint: 4 weeks | — |
Countries
India
Contacts
Public ContactDr Tausif Ahmed
Cliantha Research Limited
Outcome results
None listed