Health Condition 1: F209- Schizophrenia, unspecified
Conditions
Interventions
Intervention1: Clozapine 100 mg orally disintegrating tablets: Clozapine 100 mg orally disintegrating tablets
Control Intervention1: Reference product: CLOZAPINE 100 mg orally disintegrating tablets T
Sponsors
Bionpharma, Inc.,
Azidus Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: Male and female patients aged 18 years and older with a BMI between 18.50 30.00 kg per sq m and body weight more than 50 kg. Patients with a clinical diagnosis of schizophrenia who have been receiving a stable dose of Clozapine for at least 3 months prior to randomization and are currently receiving Clozapine 100 mg tablets twice daily. Patients with normal vital signs and general clinical examination findings, or findings considered clinically insignificant by the investigator. Patients with hepatic, renal, hematopoietic, cardiac, and respiratory functions considered adequate by the investigator for participation in the study. Patients with normal or clinically insignificant 12-lead ECG findings. Patients with negative tests for drugs of abuse and alcohol prior to study participation. Patients/LAR who are able to provide written informed consent and communicate effectively
Exclusion criteria
Exclusion criteria: History of any major surgical procedure within 28 days prior to administration of the investigational product. Known hypersensitivity to Clozapine or any of its excipients. Clinically significant orthostatic hypotension. Concurrent use of antihypertensive medications or medications known to predispose to orthostatic hypotension. White blood cell count or absolute neutrophil count considered clinically unacceptable by the investigator. Presence of any medical or surgical condition that may interfere with the absorption, metabolism, or excretion of Clozapine. History of epilepsy, seizures, or conditions predisposing to seizures. Concurrent use of medications known to suppress bone marrow function. Anticipated changes in concomitant medications during the study period. Positive test results for drugs of abuse or alcohol prior to study participation. History of alcohol or drug dependence within 6 months prior to study entry. Patients considered unlikely to comply with the outpatient medication schedule. History of recurrent syncopal episodes. History or presence of clinically significant cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric, hematological, or other medical disorders considered significant by the investigator. History of chronic alcoholism, smoking, or substance abuse. Inability to abstain from tobacco-containing products during the study period. Positive test results for hepatitis B surface antigen, syphilis antibody, anti-HCV antibody, or HIV 1 & 2 antibodies. History of granulocytopenia or myeloproliferative disorders. Use of prescription, over-the-counter, or other medications within 14 days prior to dosing that may interfere with the pharmacokinetics or pharmacodynamics of Clozapine, or which are considered clinically significant by the investigator. Consumption of grapefruit or grapefruit-containing products within 10 days prior to study participation. Participation in another clinical study or blood donation within 3 months prior to study participation. Consumption of food or beverages known to interact with Clozapine within 48 hours prior to dosing, as determined by the investigator. Hospitalization for worsening of schizophrenia within 2 months prior to screening or during the screening period. History or presence of narrow-angle glaucoma. Clinically significant abnormal blood pressure or pulse rate, as determined by the investigator. Patients with difficulty swallowing or dysphagia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate bioequivalence at steady state of Clozapine100 mg orally disintegrating tablets vs CLOZAPINE 100 mg orally disintegrating tablets Teva Pharmaceuticals USA, Inc. in adult schizophrenic patients already receiving stable daily dose of Clozapine 100 mg tablet twice dailyTimepoint: after completion of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactMr Premnath L
Azidus laboratories
Outcome results
None listed