An open label, balanced, randomized, two treatments, two periods, two sequences, multiple dose, steady state crossover, bioequivalence study of Clozapine 100 mg tablets and Leponex (Clozapine) 100 mg tablets of Viatris Healthcare GmbH in Schizophrenic Patients already receiving stable daily dose of Clozapine 100 mg tablet twice daily under fed (Low-fat medium-calories breakfast) condition

Ardi Farma Ilac Pazarlama Tic. Ltd1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2026年4月27日最近更新: 2026年4月10日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 30
试验地点: 1

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

This is an open label, randomized, two treatment, two period, two sequence crossover bioequivalence study conducted at steady state in adult schizophrenic patients who are already receiving a stable dose of clozapine 100 mg twice daily at 12 hour intervals. The objective of the study is to demonstrate bioequivalence between Clozapine Tablets 100 mg and Leponex Clozapine 100 mg Tablets manufactured by Viatris Healthcare GmbH. Eligible patients will receive both the test and reference formulations under steady state conditions, and pharmacokinetic parameters such as Cmax at steady state and AUC over the dosing interval will be evaluated to assess bioequivalence. Safety and tolerability will also be monitored throughout the study.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: None

入排标准

年龄范围: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•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.

排除标准

•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.
•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.

研究者

发起方

Ardi Farma Ilac Pazarlama Tic. Ltd

申办方类型

Pharmaceutical industry-Global

责任方

Principal Investigator

主要研究者

Dr S Sathish Kumar

Azidus laboratories

研究点 (1)

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