CTRI/2019/06/019832 [Registered on: 25/06/2019] Trial Registered Prospectively
Last Modified On:
18/10/2021
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Generic drug trial seeking for approval of generic paliperidone 1 month injection for treatment of Schizophrenia.
Scientific Title of Study
A Pivotal, Multiple-Dose, Pharmacokinetic Bioequivalence Trial Comparing Generic to Reference Medicinal Product of Paliperidone Palmitate Prolonged-Release Injectable Suspension (100 mg) in Subjects with Schizophrenia
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
TOL3033B, Version 3.0, Version Date 01/Apr/2019
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
Address
Clinical Operations Department, Room Number 2, East Wing, Second Floor Skoda House Opposite L J Campus S G Highway Sarkhej Ahmedabad – 382210
Ahmadabad GUJARAT 382210 India
Phone
9637555304
Fax
Email
sandeep.singh@cbccusa.com
Details of Contact Person Scientific Query
Name
Dr Sandeep Singh
Designation
Director Operations
Affiliation
CBCC Global Research LLP
Address
Clinical Operations Department, Room Number 2, East Wing, Second Floor Skoda House Opposite L J Campus S G Highway Sarkhej Ahmedabad – 382210
Ahmadabad GUJARAT 382210 India
Phone
9637555304
Fax
Email
sandeep.singh@cbccusa.com
Details of Contact Person Public Query
Name
Dr Sandeep Singh
Designation
Director Operations
Affiliation
CBCC Global Research LLP
Address
Clinical Operations Department, Room Number 2, East Wing, Second Floor Skoda House Opposite L J Campus S G Highway Sarkhej Ahmedabad – 382210
3rd Floor, Research Room, Divyam Hospital, Block no 84, Palsana Cross road, National Highway No: 8, Palsana,
Surat-394315
Surat GUJARAT
9825137443
drtcshah@gmail.com
Dr Sarika Dakshikar
Gokuldas Tejpal Hospital
1st floor, Department of Psychiatry, Gokuldas Tejpal Hospital, Grant Govt Medical college & Sir J.J. group of Hospitals,
Mumbai-400001
Mumbai MAHARASHTRA
9819970710
sarikadakshikar@gmail.com
Dr Bakul Chandrakant Buch
Hatkesh Healthcare Foundation
2nd Floor, Research Room , Hatkesh Healthcare foundation, Saraswati Mandir complex, Nr Bhutnath Temple, Near Domadiya Vadi, college Rd,
Junagadh-362001
Junagadh GUJARAT
9825220330
bakulbuch@gmail.com
Dr Dalaya Nitin Veersingh
Life Point Multispecialty Hospital
3rd Floor, Research Department, Life point Multispecialty Hospital, 145/1 Mumbai-Bangalore Highway, Near Hotel Sayaji, Wakad,
Pune-411057
Pune MAHARASHTRA
1st Floor, Research Room, MITR Foundation, 1 Shantinagar Society, Way to CCD gully, Usmanpura, Ashram Road, Ahmedabad-380013 Ahmadabad GUJARAT
9824096430
tarak_mitr@yahoo.co.in
Dr Radhika Reddy
Old Govt. General Hospital
2nd floor, Clinical Research Room, Old Govt. General hospital (associated by Siddhartha Medical college), Hanuman pet, Two town,
Vijaywada-520002
Krishna ANDHRA PRADESH
9848229798
rrvemireddy@yahoo.com
Dr Kulkarni Krishnaji Siddo
Oyster & Pearl Hospitals
4th Floor, O & P Research Room, Oyster and Pearl Hospital, room No 504, 1671-75 Ganeshkhind road, Near Hotel Pride, Shivajinagar,
Pune- 411005
Pune MAHARASHTRA
Sri Ramchandra Institute of Higher Education and Research (SRIHER)
Basement, Clinical Research Room, Dental Hospital Building, Sri Ramchandra Institute of higher education and research, no 1 Ramchandra Nagar, Porur, Chennai-600116 Chennai TAMIL NADU
9841019910
sathianathen6@yahoo.com
Dr Kalrav Mistry
Svayambhu Hospital
Research Department, First Floor, Opposite RAF camp, SP ring road, vastral, Ahmedabad- 382418, India. Ahmadabad GUJARAT
1. Able to understand the investigational nature of this study and provide written informed consent prior to the participation in the trial
2.Subjects between 18 and 65 years of age (both inclusive)
3. Subjects having body mass index (BMI) between 18.50 to 30.00 kg/m2 (both inclusive)
4. Subjects diagnosed with schizophrenia as per DSM-IV-TR (or later) criteria.
5. Acceptable hematology status:
a. Hemoglobin ≥ 9 g/dL
b. Absolute neutrophil count (ANC) ≥ 1500 cells/μL
c. Platelet count ≥ 100,000 cells/μL
6. Acceptable liver function:
a. Alanine aminotransferase (ALT) ≤ 2X upper limit of normal (ULN)
b. Aspartate aminotransferase (AST) ≤ 2X ULN
c. Bilirubin < 1.2 mg/dL
d. Alkaline phosphatase ≤ 2X ULN
7. Subjects with creatinine clearance ≥ 80 mL/minute
8. Female subjects with negative serum pregnancy test at screening.
9. Subjects who agree to use adequate contraception (e.g., hormonal, chemical, double-barrier, or abstinence) while in the study and for 3 months after study participation is discontinued
10. No history of addiction to any recreational drug or drug dependence or alcohol addiction within 12 months prior to randomization
11. Must be able to attend regularly scheduled study center appointments and be able to abide by all study requirements
ExclusionCriteria
Details
1. Hypersensitivity to paliperidone palmitate or risperidone or to any of the excipients of the formulations
2. Subjects who are in an acutely agitated or severely psychotic state
3. Subjects who have current thoughts of suicide (suicidal ideation) or violent tendencies at the time of screening
4. Subjects who have a Rating of >4 (moderately ill) on the CGI-S scale at screening
5. History or presence of neuroleptic malignant syndrome (NMS), tardive dyskinesia, dementia-related psychosis, Parkinson’s disease or epilepsy/seizures
6. History or presence of any uncontrolled debilitating systemic disease (e.g., cardiovascular disease, hypertension, diabetes mellitus etc.)
7. Current or anticipated use during study participation of any of the prohibited medications. (See Appendix 14.1)
8. Subjects with congenital long QT syndrome (QTc of > 470 msec for females and > 450 msec for males) or presence of severe cardiovascular disease defined as having required cardiovascular surgery or the occurrence of incapacitating myocardial infarction within past 12 months
9.Subjects with history of arrhythmia
10. Subjects with positive urine screen for drugs of abuse (Except for benzodiazepine which is a permissible medication supported by prescription)
11. Smokers who smoke ≥ 10 cigarettes or equivalent per day
12. Major surgical procedure (including periodontal) within 28 days of first IP dosing
13. Current surgical or other non-healing wounds
14. Subjects with positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
15. Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study or that could limit adherence to study requirements
16. Participation in any clinical study within 90 days of first IP dosing
17. Donation and/or loss of ≥ 350 mL (1 unit) of blood within 90 days of first IP dosing
18. Lactating women
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pre-numbered or coded identical Containers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To establish the multiple dose steady-state bioequivalence of equivalent doses of TEST [PP-PRIS 100 mg (Tolmar)] and RMP [Xeplion 100 mg (Janssen-Cilag International NV)]
Pre-dose blood sample(within 5minutes prior to dosing)- Day:1,85(Dose-4),113 (Dose-5),141 (Dose-6); Day 142 24 hours; Day 143 48 hours,Day 144 72 hours,Day 145 96 hours(± 60 minutes).Day 146-120 hours, Day 147-144 hours, Day 148-168 hours, Day 149-192 hours, Day 150-216 hours, Day 151-240 hours, Day 152-264 hours, Day 154-312 hours, Day 156-360 hours, Day 158-408 hours, Day 161-480 hours, Day 165-576 hours, Day 169-672 hours (±4 hours)
Secondary Outcome
Outcome
TimePoints
To assess safety and tolerability of RMP and TEST in subjects who are exposed to the investigational product (IP; either TEST or RMP).
Pre-dose blood sample(within 5minutes prior to dosing)- Day:1,85(Dose-4),113 (Dose-5),141 (Dose-6); Day 142 24 hours; Day 143 48 hours,Day 144 72 hours,Day 145 96 hours(± 60 minutes).Day 146-120 hours, Day 147-144 hours, Day 148-168 hours, Day 149-192 hours, Day 150-216 hours, Day 151-240 hours, Day 152-264 hours, Day 154-312 hours, Day 156-360 hours, Day 158-408 hours, Day 161-480 hours, Day 165-576 hours, Day 169-672 hours (±4 hours)
Target Sample Size
Total Sample Size="320" Sample Size from India="320" Final Enrollment numbers achieved (Total)= "296" Final Enrollment numbers achieved (India)="296"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
The Study isA Pivotal, Multiple-Dose, Pharmacokinetic Bioequivalence Trial Comparing Generic to Reference Medicinal Product of Paliperidone Palmitate Prolonged-Release Injectable Suspension (100 mg) in Subjects with Schizophrenia
Primary Objective:To establish the multiple dose steady-state bioequivalence of equivalent doses of TEST [PP-PRIS 100 mg (Tolmar)] and RMP [Xeplion 100 mg (Janssen-Cilag International NV)]
Secondary Objective:To assess safety and tolerability of RMP and TEST in subjects who are exposed to the investigational product (IP; either TEST or RMP).