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CTRI Number  CTRI/2019/02/017754 [Registered on: 21/02/2019] Trial Registered Prospectively
Last Modified On: 14/10/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Bioequivalence study of Paliperidone Palmitate in schizophrenia patients 
Scientific Title of Study   A multicenter, randomized, open label, two treatment, two period, two sequence, multiple-dose, two-way, crossover, steady-state bioequivalence study of Paliperidone Palmitate 156 mg/ml Injectable Suspension of Amneal Pharmaceuticals Company GmbH, with INVEGA® SUSTENNA® (paliperidone palmitate) extended-release injectable suspension 156 mg/ml Manufactured for Janssen Pharmaceuticals, Inc. Titusville, NJ 08560, USA in schizophrenia patients 
Trial Acronym  15-VIN-526 
Secondary IDs if Any  
Secondary ID  Identifier 
15-VIN-526, Version 2.0 Dated 27/Dec/2018  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sandeep Singh 
Designation  Director Operations 
Affiliation  CBCC Global Research LLP India 
Address  Clinical Operations Department, Room Number 2, East Wing, Second Floor Skoda House Opposite L J Campus S G Highway Sarkhej

Ahmadabad
GUJARAT
382210
India 
Phone  9637555304  
Fax  9726434204  
Email  sandeep.singh@cbccusa.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandeep Singh 
Designation  Director Operations 
Affiliation  CBCC Global Research LLP India 
Address  Clinical Operations Department, Room Number 2, East Wing, Second Floor Skoda House Opposite L J Campus S G Highway Sarkhej

Ahmadabad
GUJARAT
382210
India 
Phone  9637555304  
Fax  9726434204  
Email  sandeep.singh@cbccusa.com  
 
Details of Contact Person
Public Query  
Name  Dr Sandeep Singh 
Designation  Director Operations 
Affiliation  CBCC Global Research LLP India 
Address  Clinical Operations Department, Room Number 2, East Wing, Second Floor Skoda House Opposite L J Campus S G Highway Sarkhej

Ahmadabad
GUJARAT
382210
India 
Phone  9637555304  
Fax  9726434204  
Email  sandeep.singh@cbccusa.com  
 
Source of Monetary or Material Support  
Amneal Pharmaceuticals Company GmbH 
 
Primary Sponsor  
Name  Amneal Pharmaceuticals Company GmbH 
Address  Turmstrasse 30, 6312 Steinhausen, Switzerland Tel: 41 41 723 20 65 Fax: 41 41 723 20 62 E-mail: jayeshd@amneal.com 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sandip Shah  GMERS Medical College and Hospital  Department of Psychiatry Room no 204 2nd floor GMERS medical college and hospital Gotri road Gotri Vadodara-390021
Vadodara
GUJARAT 		 02652398008

hod.psy.gotri@gmail.com 
Dr Sarika Dakshikar  Gokuldas Tejpal Hospital  Grant Government Medical College and Sir J J Group of Hospital Byculla Mumbai-400001
Mumbai
MAHARASHTRA 		 9819970710

sarikadakshikar@gmail.com 
Dr Niket Kasar  KEM Hospital and Research Centre  Sardar Moodliar Road Rasta Peth Pune-411011
Pune
MAHARASHTRA 		 9823783083

niketkasar2010@gmail.com 
Dr Bheemsain Tekkalaki  KLES Dr. Prabhakar Kore Hospital and Medical Research Centre  KLES Dr Prabhakar Kore Hospital and Medical Research Centre Nehru Nagar Belgaum–590010
Belgaum
KARNATAKA 		 9164137499

tbheemsain@gmail.com 
Dr Nitin Dalaya  Lifepoint Multispeciality Hospital  145/1 Mumbai Bangalore Highway Near Hotel Sayaji Wakad Pune-411057
Pune
MAHARASHTRA 		 9552503210

drdalaya@nityanandrehab.com 
Dr Poorav Patel  Medistar Multispeciality Hospital  Trimurti Avenue Medistar Cross road NH-8 Industrial Area Himmatnagar-383001
Sabar Kantha
GUJARAT 		 9428772609

drpooravpatel@gmail.com 
Dr Tarak Shah  MITR Foundation  1 Shantinagar Society Way to CCD Gully Ashram Road Usmanpura Ahmedabad-380013
Ahmadabad
GUJARAT 		 9824096430

tarak_mitr@yahoo.co.in 
Dr Radhika Reddy  Old Government General Hospital  Old Government General Hospital Hanumanpet Two Town Vijayawada-520002
Krishna
ANDHRA PRADESH 		 9848229798

rrvemireddy@yahoo.com 
Dr K S Kulkarni  Oyster and Pearl Hospital  Phandis Clinic Pvt Ltd 1671-75 Ganeshkhind Road Shivajinagar Pune-411005
Pune
MAHARASHTRA 		 9822116995

kulkarniks@hotmail.com 
Dr Nehal Shah  Sanjivani Superspeciality Hospital  1 New Uday Park Society Near Sunrise Park Vastrapur Ahmedabad-380015
Ahmadabad
GUJARAT 		 9925049569

doctornehal@gmail.com 
Dr Ramashanker Yadav  Saviour Multispeciality Hospital  Near Bharat Petrol Pump Lakhudi Talav Stadium Road Navrangpura Ahmedabad-380014
Ahmadabad
GUJARAT 		 8264049261

yadavramashanker@gmail.com 
Dr Umesh Nagapurkar  Sujata Birla Hospital and Medical Research Centre  Opp to Bytco College Nashik Pune Highway Nashik Road Nashik-422101
Nashik
MAHARASHTRA 		 9823146088

umeshanjali@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
Ethics Committee MITR Foundation  Approved 
Institutional Ethics Committee Grant Government Medical College and Sir J.J Group of Hospital  Approved 
Institutional Ethics Committee KLE University  Submittted/Under Review 
Institutional Ethics Committee Siddhartha Medical College and Govt. General Hospital  Approved 
Institutional Human Ethics Committee GMERS Medical College  Submittted/Under Review 
KEM Hospital Research Center Ethics Committee  Approved 
LPR Ethics Committee  Approved 
Medistar Hospital Ethics Committee  Approved 
O and P Institutional Ethics Committee  Approved 
Sanjivani Hospital Ethics Committee  Approved 
Saviour Hospital Ethics Committee  Approved 
Yash Society Ethics Committee Sujata Birla Hospital and Medical Research Centre  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 
Comparator Agent  INVEGA® SUSTENNA® (Paliperidone Palmitate) extended-release injectable suspension 156 mg/ml  Each patient will receive dose of INVEGA® SUSTENNA® (Paliperidone Palmitate) 156 mg / ml as intramuscular injection in a cross-over design at same injection (Deltoid or Gluteal) site for 6 doses in each period. 
Intervention  Paliperidone Palmitate 156 mg/ml Injectable Suspension  Each patient will receive dose of Paliperidone Palmitate 156 mg / ml as intramuscular injection in a cross-over design at same injection (Deltoid or Gluteal) site for 6 doses in each period. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Men and women, 18 years of age or older with a body mass index of 18.50-30.00 kg/m2 at screening (both inclusive).
2. Ability to provide informed consent prior to participation in the study.
3. Women of childbearing potential (except for those who have completed one year since menopause or have gone through hysterectomy or bilateral tubal ligation within past 6 months) must have a negative pregnancy test at prior to enrolment in the study and must agree to use an adequate method of contraception during the study period.
4. Patients with schizophrenia and who are already receiving a stable regimen of Paliperidone palmitate extended release suspension via the intramuscular route.
5. No history of addiction to any recreational drug or drug dependence.
6. No participation in any clinical study within the past 60 days.
7. Clinically acceptable ECG in the opinion of an Investigator.
 
 
ExclusionCriteria 
Details  1. A history of allergic or adverse reactions to Paliperidone palmitate or risperidone or any comparable or similar product.
2. A history of severe hepatic impairment, drug induced leukopenia/neutropenia.
3. Elderly patients with dementia-related psychosis.
4. Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, idiopathic Parkinson’s disease, epilepsy or risk for seizures, neuropsychiatric infection, neuroleptic malignant syndrome or disease.
5. A total white blood cell count below 3000/cmm and an absolute neutrophil count below 1500/cmm.
6. History or presence of circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval, including: bradycardia, clinically significant abnormality on the ECG, demonstration of repeated prolonged QTc (> 450 ms for male and > 470 ms for female patient), cardiac arrhythmias, myocardial infarction or unstable heart disease.
7. Are unable to stabilize on antipsychotic medication tapering during the study.
8. History of significant orthostatic hypotension, syncopal episodes and known case of cardiovascular or cerebro vascular disease and patients predispose to hypotension. (i.e., 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).
9. A medical or surgical condition that might interfere with the absorption, metabolism, or excretion of Paliperidone.
10. Expected changes in concomitant medications during the period of study.
11. Have a history of alcohol or drug-dependence during the 6-month period immediately prior to Screening.
12. Positive test results for urine drug scan or breath alcohol test at baseline.
13. Patients who are:
Pregnant
Breast feeding
Male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the study
Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from any prior major surgery
Patients with known positivity for human immunodeficiency virus (HIV), HBsAg or HCV
Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent
14. Subjects taking medications that irreversibly inhibit platelet function or anticoagulants.
15. Subject with metabolic disorders (uncontrolled diabetes mellitus and lipid abnormalities), clinically significant Hyperprolactinemia, cognitive and motor Impairment.
16. History of difficulty with donating blood or difficulty in accessibility of veins.
17. Donation of blood (1 unit or 360 ml) within 90 days prior to receiving the first dose of investigational medicinal product in the study. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To characterize the pharmacokinetic profile of the Test product – Paliperidone Palmitate 156 mg/ml Injectable Suspension of Amneal Pharmaceuticals Company GmbH, compared to INVEGA® SUSTENNA® (paliperidone palmitate) extended-release injectable suspension 156 mg/ml Manufactured for Janssen Pharmaceuticals, Inc.  Day 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the safety and tolerability of Paliperidone Palmitate 156 mg/ml Injectable Suspension in schizophrenia patients who are already receiving a stable regimen of Paliperidone Palmitate extended release suspension via the intramuscular route.  Throughout Study Period 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   08/05/2019 
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="1"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Suspended 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This study is A multicenter, randomized, open label, two treatment, two period, two sequence, multiple-dose, two-way, crossover, steady-state bioequivalence study of Paliperidone Palmitate 156 mg/ml Injectable Suspension of Amneal Pharmaceuticals Company GmbH, with INVEGA® SUSTENNA® (paliperidone palmitate) extended-release injectable suspension 156 mg/ml Manufactured for Janssen Pharmaceuticals, Inc. Titusville, NJ 08560, USA in schizophrenia patients.

Primary Objective: To characterize the pharmacokinetic profile of the Test product – Paliperidone Palmitate 156 mg/ml Injectable Suspension of Amneal Pharmaceuticals Company GmbH, compared to INVEGA® SUSTENNA® (paliperidone palmitate) extended-release injectable suspension 156 mg/ml Manufactured for Janssen Pharmaceuticals, Inc. Titusville, NJ 08560, USA in schizophrenia patients who are already receiving a stable regimen of paliperidone palmitate extended release suspension intramuscularly and to assess their bioequivalence.

Secondary Objective: To monitor the safety and tolerability of Paliperidone Palmitate 156 mg/ml Injectable Suspension in schizophrenia patients who are already receiving a stable regimen of paliperidone palmitate extended release suspension via the intramuscular route.

 
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