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CTRI Number  CTRI/2017/02/007884 [Registered on: 16/02/2017] Trial Registered Prospectively
Last Modified On: 10/12/2021
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   bioequivalence study of Paliperidone prolonged-release 9 mg tablets of Pharmathen S.A., Greece in comparison with INVEGA 9 mg prolonged-release tablets in adult schizophrenic patients 
Scientific Title of Study   A randomized, multi center, open label, balanced, two-treatment, three-period, three-sequence, multiple dose, partial replicate crossover, steady-state bioequivalence study of Paliperidone prolonged-release 9 mg tablets of Pharmathen S.A., Greece in comparison with INVEGA 9 mg prolonged-release tablets (Marketing Authorisation Holder: Janssen-Cilag International NV Belgium) in adult schizophrenic patients under fasting conditions. 
Trial Acronym  16-VIN-0596 
Secondary IDs if Any  
Secondary ID  Identifier 
16-VIN-0596 version 01 dated 10-Oct-2016  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashoka Kumar Singh 
Designation  General Manager- HOD-Clinical Operations 
Affiliation  Veeda Clinical Research Pvt. Ltd.  
Address  Veeda Clinical Research Pvt. Ltd. Shivalik Plaza-A, Near IIM, Ambawadi, Ahmedabad
NA
Ahmadabad
GUJARAT
380 015
India 
Phone  079-30013000  
Fax    
Email  ashoka.singh@veedacr.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Yogesh Patel 
Designation  Sr. Manager Clinical Operations 
Affiliation  Veeda Clinical Research Pvt. Ltd.  
Address  Veeda Clinical Research Pvt. Ltd. Shivalik Plaza-A, Near IIM, Ambawadi, Ahmedabad
NA
Ahmadabad
GUJARAT
380 015
India 
Phone  079-30013000  
Fax    
Email  yogesh.ap@veedacr.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashoka Kumar Singh 
Designation  General Manager- HOD-Clinical Operations 
Affiliation  Veeda Clinical Research Pvt. Ltd. 
Address  Veeda Clinical Research Pvt. Ltd. Shivalik Plaza-A, Near IIM, Ambawadi, Ahmedabad
NA
Ahmadabad
GUJARAT
380 015
India 
Phone  079-30013000  
Fax    
Email  ashoka.singh@veedacr.com  
 
Source of Monetary or Material Support  
Pharmathen S.A. Greece Dervenakion 6, 15351, Pallini,Athens, Greece, Tele: 302106665067 Ext: 354 Fax: 302106604583 
 
Primary Sponsor  
Name  Pharmathen SA Greece 
Address  Pharmathen S.A. Dervenakion 6 , 15351, Pallini, Athens, Greece  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Veeda Clinical Research Pvt Ltd  Veeda Clinical Research Pvt Ltd Shivalik Plaza Near I I M Ambawadi Ahmedabad 380 015 India  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Timir Shah  Divyam Hospital   4th floor Department of psychatry Divyam Hospital Maher Park A wing Nr Athwa Gate Ring Road, Surat 395 001 Gujarat India
Surat
GUJARAT 		 9825137443

divyamhospital@gmail.com 
Dr Rajendra Anand  Kanoria Hospital and Research Centre  Ground Floor Head of department Chamber Kanoria Hospital and Research Centre Airport Gandhinagar Highway, Village Bhat Dist Gandhinagar 382428 Gujarat India
Gandhinagar
GUJARAT 		 9824017400

drrajendraanand@yahoo.com 
Dr Ashok Goyal  Malpani Multispeciality Hospital  Sp 6 Road no 1 VKI area Sikar Road Jaipur 302013 Rajasthan India
Jaipur
RAJASTHAN 		 9828809333

goyalashokdr@gmail.com 
Dr Vaishal Vora  Ratandeep Multispeciality Hospital  Ratandeep Multispeciality Hospital 2nd floor Nakshtra complex above HDFC bank Maninagar cross roads Ahmedabad 380008 Gujarat India
Ahmadabad
GUJARAT 		 9825440891

vnvora@gmail.com 
Dr Nehal Shah  Sanjivani Super speciality Hospital Pvt Ltd  1 New Uday Park Society Near Sunrise Park Vastrapur Ahmadabad 380015 Gujarat India
Ahmadabad
GUJARAT 		 9925049569

doctornehal@gmail.com 
Dr Bakul Buch  Shree Hatkesh Healthcare Foundation  Saraswati Mandir Complex Opposite Bhutnath Temple Junagadh 362001 Gujarat India
Junagadh
GUJARAT 		 9825220330

bakulbuch@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Divyam Hospital Ethical Review Board ethics Committee Divyam Hospital Ethical Review Board  Approved 
Institutional Ethics Committee Malpani Multispeciality Hospital  Approved 
Kanoria Ethics Committee Kanoria Hospital and Research Centre  Approved 
Ratandeep Institutional Ethics Committee Ratandeep Multispeciality Hospital  Approved 
Sanjivani Hospital Ethics Committee  Approved 
Shree Hatkesh Healthcare Foundation Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
No Objection Certificate 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Schizophrenia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  INVEGA 9 mg prolonged release tablets Marketing authorization holder Janssen Cilag International NV Belgium  As per randomization schedule, the patient will receive test product (T) twice during three treatment period. 
Intervention  Paliperidone prolonged Release 9 mg tablets of Pharmathen S.A. Greece.  As per randomization schedule, the patient will receive test product (T) twice during three treatment period. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Men and women aged 18-65 years (both inclusive) having clinical diagnosis of schizophrenia (DSM IV-TR).
2. Have body mass index of 18.5 to 30kg/m2.
3. Schizophrenic patients who are on stable dose of paliperidone9 mg prolonged-release tablet once daily or clinically indicated to receive paliperidone9 mg prolonged-release tablet once daily as per Investigator’s opinion.
4. Sexually active women, unless surgically sterile (at least 6 months prior to Study drug administration) or postmenopausal for at least 12 consecutive months, must agree to use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to study drug administration] sexual partner) for at least 4 weeks prior to study drug administration, during the study and up to 30 days after the last dose of study drug.
And
Sexually active women must have a negative pregnancy test (at screening, before check-in on day 0) as well as must be non-lactating at screening.
5. In case of male patients: Either partner or patient must agree to use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during the study and up to 30 days after the last dose of study drug.
6. Willing and able to comply with housing, restrictions and other protocol requirements as indicated by signed written informed consent witnessed by a legally acceptable representative.
7. Adequate hematological parameters at screening defined by:
Total white blood cell count  4000/c.mm
ANC  1500/mm3
Platelet count  75,000/mm3
Haemoglobin ≥ 9.0 gm/dl
8. Adequate hepatic function at screening as defined by:
Bilirubin ≤ 1.5 X ULN (upper limit of normal)
AST/ ALT ≤ 2.5 X ULN
9. Adequate renal function at screening as defined by S. creatinine ≤1 X ULN or creatinine clearance ≥80 ml/min.

 
 
ExclusionCriteria 
Details  1. A history of allergic reactions/hypersensitivity to the active substance (paliperidone), risperidone or other excipients of study drug.
2. Subject with history of hospitalisation for an exacerbation of schizophrenia within two months prior to screening and during the screening period.
3. Concurrent primary psychiatric (other than schizophrenia) or neurological diagnosis, including neurologic malignant syndrome, organic mental disorder, severe tardive dyskinesia, Parkinson’s disease, history or presence of epilepsy or risk for seizures, history of multiple syncopal episodes.
4. Subject who is having :
Clinically significant cardiac disorders (e.g. myocarditis, cardiomyopathy, bradycardia) or QTc> 500 milliseconds or Uncontrolled hypertension.
Gastrointestinal obstruction, narrowing (pathological or iatrogenic), significantly difficulty in swallowing tablet, colonic disease, condition leading to shorter gastrointestinal transit time (e.g. diseases associated with chronic severe diarrhea).
Myeloproliferative disorders (drug-induced or idiopathic).
Significant orthostatic hypotension at screening or before check-in on day 0; orthostatic hypotension will be considered when there is drop in systolic blood pressure of 30 mm Hg or more or diastolic blood pressure of 20 mm Hg or more on standing from supine measurements.
Presence of uncontrolled metabolic disorders including diabetes mellitus (HbA1c > 9%).
Significant hyperprolactinaemia or with possible prolactin-dependent tumours.
History/presence of venous thromboembolism.
5. Expected changes in concomitant medications during the period of study.
6. History of alcohol or drug abuse.
7. Positive urine drug scan test (for drugs) or alcohol breath test (for alcohol abuse) at screening or baseline.
8. A history of alcohol or drug dependence by Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria during the 6-month period immediately prior to study enrollment.
9. Use of any of the following medications within 14 days prior to enrolment but not limited to:
Medications known to prolong the QTc interval, [As mentioned in Annexure III]
Medicines known to lower the seizure threshold (i.e.,carbamazepine,phenothiazines or butyrophenones, clozapine, tricyclics or SSRIs, tramadol, mefloquine, etc.)
Other medicinal products or herbals which are strong inducers of CYP3A4, e.g. rifampicin and St John´s wort (Hypericumperforatum)
Medicinal products affecting gastrointestinal transit time. e.g., metoclopramide.
Divalproex sodium
Antihypertensive and other drugs known to cause postural hypotension.
Alcohol, MAOIs, CNS depressants including narcotics and benzodiazepines
Use of other drugs known to suppress bone marrow function
10. A medical or surgical condition that might interfere with the absorption, metabolism, or excretion of Paliperidone.
11. Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery.
12. Patients with known positivity for human immunodeficiency virus (HIV), HBsAg or HCV.
13. Chronic Smokers who smokes greater than or equal to 10 cigarettes or equivalent per day.
14. History of difficulty with donating blood or difficulty in accessibility of veins.
15. Compliance with outpatient medication schedule not expected as per Principal Investigator’s opinion.
16. Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study.
17. Participation in any clinical study within the past 30 days of randomization or has less than 5 half life from previous IMP receipt.
18. An unusual or abnormal diet, for whatever reason planned e.g. religious fasting during the course of the study.
19. Any condition/ abnormal baseline findings that in the Investigators’ judgment might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study e.g. low expectation of compliance to dosing or expected changes in concomitant medication that may interfere in study.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To demonstrate bioequivalence of paliperidone prolonged 9 mg tablet of Pharmathen S.A Greee VS. in comparison with
INVEGA 9 mg prolonged release tablets by Janssen Ciag International NV Belgium.  		 A total of 60 PK samples will be collected during the study. Safety assessment on Day 19 and post safety assessment on Day 28 should be collected.And after that evaluation of the sampling done.  
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the safety and tolerability profile of the study formulation.   NA 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
Final Enrollment numbers achieved (Total)= "87"
Final Enrollment numbers achieved (India)="87" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2017 
Date of Study Completion (India) 08/05/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The patients with confirmed diagnosis of Schizophrenia who are candidates for paliperidone prolong released (9 mg tablet) and who fulfill the inclusion and exclusion criteria will be randomized in study. As per randomization schedule, patient will receive test product once and reference product twice during three treatment periods, patient will be randomized to one of the three treatment sequences,i.e. TRR,RTR or RRT in each period cross over without wash out period.   
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