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CTRI Number  CTRI/2026/04/108405 [Registered on: 15/04/2026] Trial Registered Prospectively
Last Modified On: 10/04/2026
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   A Simple Study to Compare Two Clozapine 100 mg Tablet Brands in Schizophrenia Patients Taking Regular Doses, to Check if Both Work the Same Way in the Body After Food Intake 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr S Sathish Kumar 
Designation  Coordinating Investigator 
Affiliation  Azidus laboratories 
Address  23, School Road, Rathnamangalam, Vandalur, Chennai - 600127

Chennai
TAMIL NADU
620127
India 
Phone  7358076959  
Fax    
Email  ra@azidus.com  
 
Details of Contact Person
Scientific Query  
Name  Dr S Sathish Kumar 
Designation  Coordinating Investigator 
Affiliation  Azidus laboratories 
Address  23, School Road, Rathnamangalam, Vandalur, Chennai - 600127


TAMIL NADU
620127
India 
Phone  7358076959  
Fax    
Email  ra@azidus.com  
 
Details of Contact Person
Public Query  
Name  Dr S Sathish Kumar 
Designation  Coordinating Investigator 
Affiliation  Azidus laboratories 
Address  23, School Road, Rathnamangalam, Vandalur, Chennai - 600127


TAMIL NADU
620127
India 
Phone  7358076959  
Fax    
Email  ra@azidus.com  
 
Source of Monetary or Material Support  
Ardi Farma Ilaç Pazarlama Tic. Ltd, Sanayi Mah. Teknopark Bul Teknopark A1 No: 1/1A 222, Pendik Istanbul 
 
Primary Sponsor  
Name  Ardi Farma Ilac Pazarlama Tic. Ltd 
Address  Ardi Farma Ilac Pazarlama Tic Ltd Sti Teknopark Istanbul Sanayi Mah Teknopark Bulvari No 1 4A 101 34906 Pendik Istanbul Turkey 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Magesh Rajagopal  Aram Hospital  room # 1, Psychiatric department, 21, 4th Cross Street, Vayalur Rd, Ramlinga Nagar, South Extension, Tiruchirappalli, Tamil Nadu 620017
Tiruchirappalli
TAMIL NADU 		 8270723371

magdoc76@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Aram Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G988||Other disorders of nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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. 
Comparator Agent  Leponex (Clozapine) 100 mg tablets of Viatris Healthcare GmbH  The bioequivalence study is being conducted to evaluate the pharmacokinetics of test formulation in comparison to that of the comparator product. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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 intervals  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 Outcome  
Outcome  TimePoints 
NIL  Not applicable 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/04/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   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. 
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