Health Condition 1: G988- Other disorders of nervous system
Conditions
Interventions
Intervention1: Clozapine 100 mg tablets of the sponsor: The bioequivalence study is being conducted to evaluate the pharmacokinetics of test formulation in comparison to that of the comparator product
Sponsors
Ardi Farma Ilac Pazarlama Tic. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male and or non pregnant and non breast feeding female patients aged 18 years and older with a BMI between 18.50 and 30.00 kg per m2 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 taking clozapine 100 mg tablet twice daily at 12 hour intervals. Patients otherwise healthy based on medical history, vital signs and general clinical examination. Patients with normal vital parameters including blood pressure, pulse rate and temperature and normal or clinically insignificant findings on general clinical examination as judged by the investigator. Patients with hepatic, renal, hematopoietic, cardiac and respiratory functions considered appropriate for study participation by the investigator. Normal or clinically insignificant ECG findings. Negative urine test for drugs of abuse and negative alcohol breath test for both males and females and negative pregnancy test for females who do not plan to become pregnant during the study and for 3 months after study completion. Patients willing to use highly effective and complementary acceptable methods of contraception during the study and for 3 months after completion such as documented tubal sterilization, intrauterine device placed at least 7 days prior to Day 0, two barrier methods used together including cervical cap diaphragm contraceptive sponge or vaginal spermicide plus male or female condom, or absolute sexual abstinence. Patients or legally acceptable representative 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 first dose of investigational product. Known hypersensitivity to clozapine or any of the excipients. Clinically symptomatic orthostatic hypotension defined as 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. Concurrent use of antihypertensive medication or any medication that may predispose to orthostatic hypotension. Total white blood cell count below 4000 per mL or absolute neutrophil count below 2000 per mL. Any medical or surgical condition that may interfere with absorption, metabolism or excretion of clozapine. History of epilepsy or risk of seizures. Concurrent use of drugs known to suppress bone marrow function. Expected changes in concomitant medications during the study period. Positive urine test for drugs of abuse or positive alcohol breath analysis at screening or baseline. History of alcohol or drug dependence as per DSM IV criteria within 6 months prior to study entry. Patients not expected to comply with outpatient medication schedule. History of multiple syncopal episodes. History of clinically significant cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric, organic mental disorder, severe tardive dyskinesia, idiopathic Parkinson disease or hematological disorders. History of chronic alcoholism, chronic smoking or drug abuse and inability to abstain from tobacco containing products during the study. Positive test for hepatitis B surface antigen, syphilis antibody, anti HCV or human immunodeficiency virus 1 and 2 antibodies. History of granulocytopenia or myeloproliferative disorders whether drug induced or idiopathic. Use of prescription or over the counter drugs within 14 days prior to dosing that may modify the kinetics or dynamics of clozapine or any medication considered clinically significant by the investigator. Consumption of grapefruit or its products within 10 days prior to study start. Participation in another clinical study or blood donation of approximately 350 mL within 3 months prior to check in. Consumption within 48 hours prior to dosing of xanthine containing foods or drinks such as cola, chocolate, coffee or tea, citrus fruits such as lime, lemon or orange, alcohol or any food or beverage known to interact as judged by the investigator. Hospitalization for exacerbation of schizophrenia within 2 months prior to screening or during screening period. History of narrow angle glaucoma. Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg, diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg. Minor deviations of 2 to 4 mm Hg at check in may be acceptable at investigator discretion. Pulse rate below 60 per minute or above 100 per minute. Patients who are dysphagic.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate bioequivalence at steady state of Clozapine tablets 100 mg vs Leponex (Clozapine) 100 mg tablets of Viatris Healthcare GmbH in adult schizophrenic patients already receiving stable daily dose of Clozapine 100 mg tablet twice daily at 12-hour intervalsTimepoint: 00.00 hours (baseline samples) on day 07 to 10 & on day 17 to 20 and post dose samples at 00.25, 00.50, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, 05.00, 06.00, 08.00, 10.00 and 12.00 hours will be collected to estimate the blood concentrations of Clozapine. | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: Not applicable | — |
Countries
India
Contacts
Public ContactDr S Sathish Kumar
Azidus laboratories
Outcome results
None listed