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CTRI Number  CTRI/2023/09/058099 [Registered on: 27/09/2023] Trial Registered Prospectively
Last Modified On: 08/08/2024
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   To assess the bioequivalence and safety of paliperidone 100mg prolonged release suspension for injection of Sun Pharmaceutical Industries Ltd, India in schizophrenic patients  
Scientific Title of Study   A Randomized, Multicenter, Open-Label, Two-Treatment, Two-Period, Two-Sequence, Multiple-Dose, Steady-State, Crossover Bioequivalence Study of Paliperidone 100 mg Prolonged Release Suspension for Injection of Sun Pharmaceutical Industries Limited, India with Xeplion (Paliperidone) 100 mg Prolonged Release Suspension for Injection of Janssen-Cilag International NV, Belgium in Patients with Schizophrenia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
C2A02719, Version No. 01 Protocol Date 07 Mar 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kanchan Tyagi 
Designation  Senior Manager 
Affiliation  Sun Pharmaceutical Industries Limited 
Address  Sun Pharmaceutical Industries Ltd. Plot No. GP-5, Sector 18, HSIDC Gurgaon

Gurgaon
HARYANA
122015
India 
Phone  919810535518  
Fax    
Email  kanchan.tyagi@sunpharma.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Rachna Arora 
Designation  Senior Manager 
Affiliation  Sun Pharmaceutical Industries Limited 
Address  Clinical Pharmacology Unit, Sun Pharmaceutical Industries Limited, 2nd Floor HAH-Centenary Hospital, Hamdard Nagar, New Delhi

South
DELHI
110062
India 
Phone  919818001209  
Fax    
Email  rachna.arora@sunpharma.com  
 
Details of Contact Person
Public Query  
Name  Ms Simrit Reyar 
Designation  Head - Quality Control (QC) and Monitoring (Senior General Manager) 
Affiliation  Sun Pharmaceutical Industries Limited 
Address  Sun House, Western express highway, Goregaon (E) Mumbai

Mumbai
MAHARASHTRA
400063
India 
Phone  919810799354  
Fax    
Email  simrit.reyar@sunpharma.com  
 
Source of Monetary or Material Support  
Sun Pharmaceutical Industries Limited, Village Sarhaul, Sector 18, Gurugram-122015, Haryana, India 
 
Primary Sponsor  
Name  Sun Pharmaceutical Industries Limited, 
Address  Sun Pharmaceutical Industries Ltd., Plot No. 20, Second Floor, R&D-III, Sarhaul, Sector-18, Udyog Vihar Industrial Area, Gurugram – 122015, Haryana, India. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rakesh Sanghadiya  Aatman Hospital  A-403,405, 4th floor, Radhekishan Complex, 132 ring road, Nr. Jaymala Bus Stand, Isanpur, Maninagar
Ahmadabad
GUJARAT 		 9825610315

r_sanghadia@yahoo.com 
Dr Rajendra Anand  Anand Multispeciality Hospital and Research Centre  4th Floor, sarthak Mall, Mahatma Mandir Road, Sargasan, Gandhinagar-382421,Gujarat
Gandhinagar
GUJARAT 		 9824017400

drrajendraanand@yahoo.com 
Dr Nakul Vanjari  Assured Care Plus Hospital  Starplus Complex, 4th & 5th Floor, Lam Road, Near Muktidham Temple, Opp. NMC Divisional Office, Nashik Road, Nashik, Maharashtra- 422101
Nashik
MAHARASHTRA 		 9819625217

nakulv1986@gmail.com 
Dr Ashok Goyal  Bhagwan Mahavir Psychiatry and De-addiction Center  Bhagwan Mahavir Psychiatry and De-addiction Center, A unit of Sardamal Khandaka Memorial Hospital, Kalward Road, Hathoj, Jaipur-302012, Rajasthan
Jaipur
RAJASTHAN 		 9413343445

ashokgoyaldr@yahoo.com 
Dr Venu Gopal Jhanwar  Deva Institute of Healthcare  B 27/70 MN, Durgakund, Varanasi- 221005, Uttar Pradesh
Varanasi
UTTAR PRADESH 		 9935571052

vgj.dihr@gmail.com 
Dr Keyur Parmar  Kiran Neuro-Psychiatry Care  309-3rd floor, Samved complex, Jail Road, Bhavnagar-364001, Gujarat
Bhavnagar
GUJARAT 		 9909903513

drkeyurparmar@gmail.com 
Dr IVL Narasimha Rao  Manasa Hospital  Manasa Hospital, D. No. 13-1-43, Old Road, Kothapet, Guntur - 522001, Andhra Pradesh, India.
Guntur
ANDHRA PRADESH 		 9849016620

manasahospitalguntur@gmail.com 
Dr Tarak Shah  MITR Foundation  MITR Foundation, 1, Shantinagar Society, CCD Gully, B/H Holiday Inn Hotel, Ashram Road, Usmanpura, Ahmedabad, Gujarat - 380013, India
Ahmadabad
GUJARAT 		 9824096430
7927551755
tarak_mitr@yahoo.co.in 
Dr Prashant Agrawal  Pulse Hospital  2/4 Pulse Hospital, Gurudwara Road, Nehru Nagar (W), Bhilai - 490020, Chhatisgarrh
Durg
CHHATTISGARH 		 7000402146

pa181184@gmail.com 
Dr Vaishal Vora  Ratandeep Multispecialty Hospital  Ratandeep Multispecialty Hospital, Nakshatra Complex, Above HDFC bank, Maninagar Cross Roads, Maninagar, Ahmedabad, Gujarat - 380008, India
Ahmadabad
GUJARAT 		 9825440891

vnvora@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Anand Ethics Committee  Approved 
DMHC Ethics Committee  Approved 
Ethics committee ratandeep multi speciality hospital  Approved 
IEC Sardarmal Khandaka Memorial Hospital  Approved 
Institutional Ethics Committee - Assured Care Plus Hospital  Approved 
Institutional ethics committee Mansa hospital  Approved 
Institutional Ethics Committee- Pulse Hospital  Approved 
Kiran Institutional Ethics Committee  Approved 
Riddhi Medical Nursing Home Institutional Ethics Committee  Approved 
Sangini Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F209||Schizophrenia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Paliperidone  Paliperidone 100 mg prolonged release suspension for injection of Sun Pharmaceutical Industries Limited, India Dose: 100 mg to be given very 28 days for 5 months 
Comparator Agent  Xeplion  Xeplion (paliperidone) 100 mg prolonged release suspension for injection of Janssen-Cilag International NV, Belgium Dose: 100 mg to be given very 28 days for 5 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male or female patient between age of 18 and 65 years both inclusive with body mass index BMI greater than or equal to 18.00 kg per m2 and 50 kg weight for male patient and 48 kg for female patient
2. Patient and LAR must demonstrate adequate decision-making ability to make an informed decision about participating in this study by providing a written informed consent
3. Patient with documented diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders Fifth Edition DSM V or latest version criteria refer Appendix I
4. Patients who are clinically stable and not hospitalized for exacerbation of psychiatric symptoms during 3 months before screening and till randomization
5. Patients who are receiving Paliperidone 100 mg prolonged release suspension for injection at a dose 100mg per mL via the intramuscular route and have completed at least two maintenance doses prior to randomization or patients on a stable dose of risperidone long-acting injection 50mg dose administered every 2 weeks consecutively for at least 6 doses
NOTE For the patients who will enter in to the stabilisation period, the criteria will be evaluated during screening part II
6. Acceptable hematology status
a. Hemoglobin greater than or equal to 9 g per dL
b. Absolute neutrophil count ANC greater than or equal to 1500 cells per microlitre
c. Platelet count greater than or equal to 100000 cells per microlitre
7. Acceptable liver function
a. Alanine aminotransferase ALT less than 5.0 times upper limit of normal ULN
b. Aspartate aminotransferase AST less than 5.0 times ULN
c. Total bilirubin less than 1.5 mg per dL
d. Alkaline phosphatase less 5.0 times ULN
8. Patients with creatinine clearance greater than or equal to 80 mL per minute calculated using the Cockcroft-Gault equation
9. Non-smokers
10. Female patients must be post-menopausal at least 1 year or surgically sterile or are ready to use an effective method of birth control Female of childbearing potential must have a negative serum pregnancy test at the screening visit
11. Male patients must agree to use a barrier method of contraception for the duration of the study if sexually active with a female of childbearing potential Method of contraception should remain same throughout the study
12. Patients with no history of addiction to any recreational drug or drug dependence or alcohol addiction
13. Patient having good general health and free of any disease state or physical condition that might impair evaluation of Schizophrenia
14. Free of exposure to any unacceptable risk by study participation as per investigator opinion
 
 
ExclusionCriteria 
Details  1. Patient who is pregnant lactating or planning to become pregnant during the study
2. Patient with signs and symptoms suggesting of COVID 19 infection
3. Known hypersensitivity to paliperidone palmitate or risperidone or to any of the excipients of IP or to any other similar class of drugs
4. Patient having current thoughts of suicide that is suicidal ideation or violent tendencies at the time of screening as per investigators discretion
5. Patient with history or presence of neuroleptic malignant syndrome NMS or tardive dyskinesia dementia related psychosis Parkinsons disease or epilepsy or seizures or cognitive and motor impairment
6. Patient with history of arrhythmia
7. Patient with positive urine screen for drugs of abuse except for benzodiazepine which is a permissible medication supported by written prescription
8. Patient with positive urine alcohol test
9. Patient with history or current signs and symptoms of severe progressive or uncontrolled pulmonary cardiac gastrointestinal hepatic renal genitourinary hematological endocrine immunologic metabolic or neurological disease
10. Patient with a corrected QT interval by Bazetts formula QTcB greater than 450 msec for male or greater than 470 msec for female at screening or prior to administration of the first dose of IP or with a known history of Torsades de Points or any family member with sudden unexplained cardiac death
11. History of cardiac disease which predispose to QT prolongation like sick sinus complete AV block CHF ventricular tachycardia hypokalemia or hypocalcemia or history of taking drugs that prolong QT
12. Presence of significant orthostatic hypotension that is decrease in systolic blood pressure greater than equal to 20 mmHg or diastolic BP of greater than equal to 10 mmHg when comparing standing to supine values or uncontrolled hypertension that is systolic BP greater than or equal to 150 mmHg or diastolic BP greater than or equal to 100 mmHg or history of syncope at screening
13. Current or anticipated use of any of the prohibited medications during study participation
14. Patient with skin abnormalities or irritations at the potential injection site that is right or left gluteal or deltoid muscle as determined by the investigator
15. Patient with any other medical condition or serious intercurrent illness that in the opinion of the investigator may make it undesirable for the patient to participate in the study that would limit adherence to study requirements
16. Patient who had major surgery within 28 days prior to receiving the first dose of IP who have not recovered from prior major surgery or who have surgery scheduled during the course of the study
17. Patient with known positivity for human immunodeficiency virus HIV HbsAg and or HCV
18. Participation in any interventional clinical study within the past 90 days of randomization.
19. Donation of blood that is 1 unit or 350 ml within 90 days prior to receiving the first dose of IP in the study
20. Patient having any other clinically significant finding of the physical examination or laboratory value or any reason which in the opinion of the investigator would prevent the patient from safely participating in the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary Parameters: Cmax,SS, AUC0-Ï„, CÏ„ss
 		 At day 281 (9.3 months) 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the adverse events & to ensure the safety of patients after investigational product administration  Screening, Stabilization Period (S-1, S-7, S-28), Period I (Day 1, 29, 57, 85, 113), Period-II (day 141, 169, 197, 225, 253) & day 281 at End of study. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/12/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

A Randomized, Multicenter, Open-Label, Two-Treatment, Two-Period, Two-Sequence, Multiple-Dose, Steady-State, Crossover Bioequivalence Study of Paliperidone 100 mg Prolonged Release Suspension for Injection of Sun Pharmaceutical Industries Limited, India with Xeplion (Paliperidone) 100 mg Prolonged Release Suspension for Injection of Janssen-Cilag International NV, Belgium in Patients with Schizophrenia. Primary objective of the study is to assess the steady-state bioequivalence between Paliperidone 100 mg prolonged release suspension for injection of Sun Pharmaceutical Industries Limited, India and Xeplion (Paliperidone) 100 mg prolonged release suspension for injection of Janssen-Cilag International NV, Belgium in patients with schizophrenia.

 
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