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CTRI Number  CTRI/2018/08/015469 [Registered on: 24/08/2018] Trial Registered Prospectively
Last Modified On: 04/04/2019
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Pharmacokinetic study of paliperidone palmitate in patients with schizophrenia. 
Scientific Title of Study
Modification(s)  		 A Randomized, Multicenter, Multiple-dose, Two-treatment, Parallel, Steady State Bioequivalence Study of Paliperidone palmitate ER Injectable Suspension (546 mg; Mylan) and INVEGA TRINZA ER Injectable Suspension (546 mg; Janssen Pharmaceuticals, Inc) in subjects with Schizophrenia. 
Trial Acronym  Nil 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
MYL-1802N-1001 Version 2.0 dated 12 Sep 2018  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dharmesh Domadia 
Designation  Associate Vice President-Global Clinical Operations 
Affiliation  Cliantha Research Limited. 
Address  Room No. 01, 2nd floor, Department-Clinical Trials, Cliantha Research Limited, Opp. Pushpraj Towers, Near Judges Bungalows, Bodakdev.

Ahmadabad
GUJARAT
380054
India 
Phone  919879590828  
Fax  917966219549  
Email  ddomadia@cliantha.in  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Nil Desai 
Designation  Medical Monitor 
Affiliation  Cliantha Research Limited. 
Address  1st Floor, Department of Medical services, Garden View Corporate House No. 2, Opp. AUDA Garden, Bodakdev

Ahmadabad
GUJARAT
380054
India 
Phone  919879732959  
Fax  07966219549  
Email  nhdesai@cliantha.in  
 
Details of Contact Person
Public Query  
Name  Mr Hitesh Maheshwari 
Designation  Project Manager 
Affiliation  Cliantha Research Limited. 
Address  Room No. 08, 3rd floor, department Clinical Trials, Garden View Corporate House No. 8 Opp. AUDA Garden, Bodakdev

Ahmadabad
GUJARAT
380054
India 
Phone  917966219577  
Fax  917966219549  
Email  hmaheshwari@cliantha.in  
 
Source of Monetary or Material Support  
Mylan Laboratories Limited, Bangalore 
 
Primary Sponsor  
Name  Mylan Laboratories Limited 
Address  Mylan Laboratories Limited, Bilekahalli, Bannerghatta Road, Bangalore 560076, India.  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrRamasubramanian Chellamuthu  Ahana Hospital   LLP. No.11. Subburam Street, Gandhi Nagar, Madurai-625020, Tamil Nadu, India.
Madurai
TAMIL NADU 		 91-9843255444

dr.ramasubramanian@gmail.com 
Dr Gundugurthi Prasad Rao   Asha Hospital  Road No. 14, Banjara Hills- 500034, Hyderabad, Telangana, India
Hyderabad
ANDHRA PRADESH 		 9985900005

prasad40@gmail.com 
Dr Timir Shah  Divyam Hospital  Clinical Research Room, Department of Psychiatry,2nd Floor, Block No. 84, Palsana Cross Road, N. H. No. 8, Palsana, Surat
Surat
GUJARAT 		 919825137443

drtcshah@gmail.com 
Dr P N Suresh Kumar  IQRAA International Hospital and research centre  Civil Station (PO), Eranhipalam, Kozhikode, Calicut, Kerala 673020, India.
Kozhikode
KERALA 		 09447218825

drpnsuresh@gmail.com 
Dr Nitin Dalaya   Lifepoint Multispecialty Hospital  clinical research Room,Department of Clinical Research, 3rd Floor, 145/1, Mumbai Bangalore Highway, Near Hotel Sayaji, waked Pune
Pune
MAHARASHTRA 		 919028649053

lp.feasibility@gmail.com 
Dr Ratnakar Inamdar  Medipoint Hospital Pvt. Ltd.  Clinical research room, Clinical Research Department, 3rd Floor, 241/1, New D P Road, Aundh Baner Boundry, Baner Road, Pune
Pune
MAHARASHTRA 		 919372336885

drrinamdar@yahoo.com 
Dr Tarak Shah  MITR Foundation  Research room,Department of Psychiatry,1st Floor, No:1 Shanti Nagar Society, Way to CCD Gully, Usmanpura, Ashram Road.
Ahmadabad
GUJARAT 		 9824096430

tarak_mitr@yahoo.co.in 
Dr Radhika Reddy  Old Govt. General Hospital Associated with Govt. Siddhartha Medical College  Clinical research room,Department of Psychiatry,2nd floor,Hanumanpet, Two Town, Vijayawada
Krishna
ANDHRA PRADESH 		 919848229798

rrvemireddy@yahoo.com 
Dr K S Kulkarni   Oyster & Pearl Hospital  Room No: 504,Department of Psychiatry,5th Floor, 1671-75, Shivajinagar, Pune
Pune
MAHARASHTRA 		 919552874787

startupfeasibility@gmail.com 
Dr Vaishal Vora  Ratnadeep Multispecialty Hospital  clinical research room,Department of Psychiatry, 5th Floor, Nakshtra Complex, Above HDFC bank, Maninagar Cross Road, Maninagar, Ahmedabad
Ahmadabad
GUJARAT 		 919825440891

vnvora@gmail.com 
Dr Bakul Buch  Shri Hatkesh Healthcare Foundation  Clinical research room,Department of Psychiatry, 2nd floor, Saraswati Mandir Complex, Near Bhutnath Temple, College Road, Junagadh
Junagadh
GUJARAT 		 9825220330

bakulbuch@gmail.com 
Dr Ramanathan Sathianathan   Sri Ramchandra Medical College and Research Institute  Central Research Facility, Clinical Trial Division, Department of Psychiatry,floor Basement,Dental Block-Basement, No.1, Ramchandra Nagar, Porur, Chennai
Chennai
TAMIL NADU 		 919841019910

sathianathen6@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
Divyam Hospital Ethical review board  Approved 
Ethics Commitee, Asha Hospital  Approved 
Ethics committee Hatkesh Health care foundation  Approved 
Ethics Committee MITR Foundation  Approved 
Ethics Committee Radianz Healthcare and research  Approved 
Ethics Committee, Ratnadeep Multispecialty Hospital  Approved 
Institutional Ethics Commitee, IQRAA International hospital and research centre  Approved 
Institutional Ethics Committee, Siddhartha Medical College & Govt. General Hospital   Approved 
Institutional Ethics Committee, Sri Ramchandra Medical College and Research Institute  Approved 
Lifepoint research- Ethics Committee  Approved 
O & P Institutional Ethics Committee  Approved 
Penta-Med Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F209||Schizophrenia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  INVEGA TRINZA(paliperidone palmitate) extended-release injectable suspension 546 mg of Janssen Pharmaceuticals, Inc. Titusville, NJ 08560  INVEGA TRINZA(paliperidone palmitate) extended-release injectable suspension 546 mg. Administration: IM: 90 days cycle  
Intervention  Paliperidone palmitate Extended-Release Injectable Suspension 546 mg of Mylan Laboratories Limited, India  Paliperidone palmitate Extended-Release Injectable Suspension 546 mg. Administration: IM: 90 days cycle  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Men or non-pregnant, non-lactating females aged 18-65 years (inclusive) having clinical diagnosis of schizophrenia.
2.Subjects with Body Mass Index (BMI) less than or equal to 35 but greater than or equal to 18 at screening and randomization.
3.Subjects who are already receiving a stable regimen of the 156 mg of monthly paliperidone palmitate extended release suspension or 546 mg of the three-month paliperidone palmitate extended release suspension via the intramuscular route prior to randomization.
4.Subjects with established tolerability to oral paliperidone/risperidone or injectable paliperidone prior to screening.
5.Subjects who are clinically stable and not hospitalized for exacerbation of psychiatric symptoms during 3 months before randomization.
6.Adequate hematological parameters at screening and randomization.
7.Adequate hepatic and renal function at screening and randomization.
8.Subject and LAR must demonstrate adequate decision-making ability to make a choice about participating in this study and provide written informed consent to participate. Agree to comply with the visit schedule and other requirements of the study 
 
ExclusionCriteria 
Details  1.History of known hypersensitivity to paliperidone, risperidone, or to any excipients in study medications.
2.Subjects with dementia related psychosis.
3.Subjects with a history of Neuroleptic Malignant Syndrome (NMS) while on treatment with antipsychotics.
4.History or presence of circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with use of drugs that prolong QTc interval
5.Presence of uncontrolled metabolic disorders.
6.Subjects with known cardiovascular disease.
7.Subjects with clinically significant hyperprolactinemia or with possible prolactin dependent tumor.
8.History of severe hepatic impairment or drug induced leukopenia/neutropenia/ agranulocytosis.
9.Subjects with Clinical Global Impression - Severity of illness (CGIS) score of 5 or more.
10.Subjects with history or presence of tardive dyskinesia, seizures, idiopathic Parkinson’s disease, cognitive and motor impairment.
11.Subjects who are on active treatment with drugs that are known to interact with paliperidone.
12.Have a history of alcohol or drug-dependence as per DSM-V criteria during the 6-month period immediately prior to screening.
13.Subjects with clinically significant laboratory investigations as per the investigator’s judgment.
14.Attempted suicide within 12 months before screening or are at imminent risk of suicide or violent behavior as clinically assessed by the investigator.
15.Male or female of childbearing potential unwilling to use adequate methods of contraception throughout the study.
16.Subjects who had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery, or whom have surgery scheduled during the course of the study.
17.Subjects with known positivity for human immunodeficiency virus (HIV), HBsAg or HCV.
18.Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product in the study.
19.Any reason which, in the opinion of the Principal Investigator or Co-Investigator, would prevent the subject 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 
To demonstrate the bioequivalence of Mylan’s Paliperidone Palmitate
Extended-Release Injectable Suspension with Janssen’s INVEGA TRINZA in subjects with Schizophrenia
 		 Day 360 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the safety and tolerability of Mylan’s Paliperidone Palmitate Extended-Release Injectable Suspension in subjects with schizophrenia  Day 360 
 
Target Sample Size   Total Sample Size="264"
Sample Size from India="264" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="264" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  		 11/09/2018 
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="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

A bioequivalence study with Paliperidone in subjects with schizophrenia.

This study includes:

·         Screening period:

Male and non-pregnant female subjects with schizophrenia will be eligible for the screening procedure. A written informed consent will be obtained prior to initiating screening procedures.

·         Treatment period:

Subjects will be randomized to receive either Mylan’s Paliperidone Palmitate Extended-Release Injectable Suspension or Janssen’s INVEGA TRINZA® (Paliperidone Palmitate) extended-release injectable suspension as intramuscular injection as per randomization schedule (either the test or reference product) in a parallel design. Subject will be randomized in a 1:1

ratio to Test or Reference product.

Main conclusion on the bioequivalence will be drawn based on the PK data obtained during last dosing interval.

Statistical analysis of pharmacokinetic parameters comparing test and reference products will be performed to assess bioequivalence. 
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