CTRI/2018/05/013703 [Registered on: 04/05/2018] Trial Registered Prospectively
Last Modified On:
24/05/2019
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 two formulations of paliperidone palmitate extended-release injectable suspension in patients with schizophrenia.
Scientific Title of Study
An Open Label, Randomized, Multicenter, Multiple-dose, Two-treatment, Single-period, Parallel,Steady State Bioequivalence Study of Paliperidone Palmitate Extended-Release Injectable Suspension 156 mg of Mylan Laboratories Limited, India and INVEGA SUSTENNA® (Paliperidone Palmitate)
Extended-Release Injectable Suspension 156 mg of Janssen Pharmaceuticals, Inc. Titusville, NJ 08560 in Subjects with Schizophrenia under Fasting Condition.
Trial Acronym
NA
Secondary IDs if Any
Secondary ID
Identifier
CRL061719, Version 1.0, dated 12-Oct-17
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Dhruv Patel
Designation
Medical Monitor
Affiliation
Cliantha Research Limited
Address
Garden View Corporate House No. 8 Opp. AUDA Garden,
Bodakdev, Ahmedabad 380054 Gujarat India
Ahmadabad GUJARAT 380054 India
Phone
07966213463
Fax
07966219549
Email
djpatel@cliantha.in
Details of Contact Person Scientific Query
Name
Dr Dhruv Patel
Designation
Medical Monitor
Affiliation
Cliantha Research Limited
Address
Garden View Corporate House No. 8 Opp. AUDA Garden,
Bodakdev, Ahmedabad 380054 Gujarat India
Ahmadabad GUJARAT 380054 India
Phone
07966213463
Fax
07966219549
Email
djpatel@cliantha.in
Details of Contact Person Public Query
Name
Mr Prasann Bavania
Designation
Project Manager
Affiliation
Cliantha Research Limited
Address
Garden View Corporate House No. 8 Opp. AUDA Garden,
Bodakdev, Ahmedabad 380054 Gujarat India
Department of Psychiatry, Clinical research Room-2nd Floor, Block No. 84, Palsana Cross Road, N. H. No. 8, Palsana, Surat - 394315 Surat GUJARAT
9825137443
drtcshah@gmail.com
Dr Vipul Singh
GSVM Medical College
Department of Psychiatry, Ward No.05 male surgery (Clinical research Room), Swaroop Nagar Kanpur –208005, UP, India Kanpur Nagar UTTAR PRADESH
7052515253
drvipulsingh.research@gmail.com
Dr T S Sathyanarayana Rao
JSS Medical College Hospital
Department of Psychiatry, Room no:1111, First floor, B-wing, M G Road, Mysore - 570005 Mysore KARNATAKA
9845282399
tssrao19@yahoo.com
Dr Rajendra Anand
Kanoria Hospital & Research Centre
Room No. 301 (Clinical Research Room),
Airport - Gandhinagar Highway, Village - Bhat, Gandhinagar - 382428
Gandhinagar GUJARAT
9824017400
drrajendranand@yahoo.com
Dr Nitin Dalaya
Lifepoint multispecialty Hospital
Department of clinical research, 3rd floor, 145/1, Mumbai Bangalore Highway, near hotel Sayaji, waked Pune-411057, Maharashtra, India Pune MAHARASHTRA
9552503201
Lp.feasibility@gmail.com
Dr Ratnakar Inamdar
Medipoint Hospital Pvt. Ltd
Clinical Research Department, 3rd Floor, 241/1, New D P Road, Aundh Baner Boundry, Baner Road, Pune – 411007, Maharastra, India Pune MAHARASHTRA
9372336885
drrinamdar@yahoo.com
Dr Mahesh Chudgar
MITR Foundation
Department of Psychiatry,1st Floor, 1, Shanti Nagar Society, Way to CCD Gully, Usmanpura, Ashram Road, Ahmedabad - 380013 Ahmadabad GUJARAT
9825412109
mahesh_mitr@yahoo.co.in
Dr Amar Shinde
Noble Hospitals Pvt. Ltd
Noble NX Building – Ground Floor (Clinical research department), Room No: 153, Magarpatta City Road, Hadapsar, Pune - 411013 Pune MAHARASHTRA
9371425020
dramarshinde2000@gmail.com
Dr Radhika Reddy
Old Govt. General Hospital
(Associated with Govt. Siddhartha Medical College), Department of Psychiatry, Hanumanpet, Two Town, Vijayawada- 520002 Krishna ANDHRA PRADESH
9848229798
rrvemireddy@yahoo.com
Dr K S Kulkarni
Oyster & Pearl Hospitals
Department of Psychiatry, Room No:504,5th Floor, 1671-75, Shivajinagar, Pune- 411005, Maharastra, India Pune MAHARASHTRA
9552874787
startupfeasibility@gmail.com
Dr Nehal Shah
Panchshil Hospital
Department of Psychiatry, 2nd Floor, New Sabarmati Railway Station, Ahmedabad - 380005 Ahmadabad GUJARAT
9925049569
doctornehal@gmail.com
Dr Vaishal Vora
Ratandeep Multispecialty Hospital
Department of Psychiatry, 5th Floor, Nakshtra Complex, Above HDFC Bank, Maninagar Cross Road, Maninagar, Ahmedabad - 380008 Ahmadabad GUJARAT
9825440891
vnvora@gmail.com
Dr Ramashanker Yadav
Shivam Hospital
Department of Psychiatry,
C-4/ Satyanarayan Society, Gor’s Kuva Jashodanagar Char Rasta, Maninagar (E), Ahmedabad -3800578, Gujarat, India
Ahmadabad GUJARAT
8264049261
yadavramashanker@gmail.com
Dr Bakul Buch
Shri Hatkesh Healthcare Foundation
Department of Psychiatry, 2nd floor, Saraswati Mandir Complex, Near Bhutnath Temple, College Road, Junagadh-362001, Gujarat, India Junagadh GUJARAT
9825220330
bakulbuch@gmail.com
Dr Ramanathan Sathianathan
Sri Ramchandra Medical college and & Research Institute
Department of Psychiatry,Basement, Central research Facility, Clinical trial division, Dental Block- Basement, No. 1, Ramchandra Nagar, Porur, Chennai - 600116 Chennai TAMIL NADU
Dose:156 mg
Route of Administration: IM
28 Days Cycle
Intervention
Paliperidone Palmitate Extended-Release Injectable Suspension
Mylan Laboratories Limited, India
Dose:156 mg
Route of Administration: IM
28 Days Cycle
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
Subjects who qualify for the study should meet the following inclusion criteria:
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.
3.Subjects who are clinically stable and no hospitalization for exacerbation of psychiatric symptoms during 3 months before screening and randomization.
4.Subjects with adequate renal function defined as creatinine clearance (Cockcroft-Gault Equation,) more than or equal to 80 mL/min.
5.Adequate hematological parameters at screening and randomization defined by:
•Total white blood cell count more than or equal to 4000/mm3
•ANC more than or equal to 1500/mm3
•Platelet count more than or equal to 100,000/mm3
•Hemoglobin more than or equal to 9.0 gm/dl
6.Adequate hepatic function at screening and randomization as defined by:
•Bilirubin less than 1.5 X ULN
•AST & ALT less than 5 X ULN
7.Agree to comply with the visit schedule and other requirements of the study.
ExclusionCriteria
Details
Subjects must not be enrolled in the study if they meet any one of the following criteria:
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 atypical 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 the use of drugs that prolong the QTc interval
5.Subjects with known cardiovascular disease (e.g., heart failure, history of myocardial infarction or ischemia, conduction abnormalities), cerebrovascular disease, or conditions that predispose the subject to hypotension (e.g., dehydration, hypovolemia, and treatment with antihypertensive medications).
6.Subjects with clinically significant hyperprolactinemia or with possible prolactin dependent tumor.
7.History of severe hepatic impairment and drug induced leukopenia/ neutropenia/ agranulocytosis.
8.Subjects with Clinical Global Impression - Severity of illness (CGI-S) score of 5 or more.
9.Subjects with history or presence of tardive dyskinesia, seizures or other conditions that potentially lower the seizure threshold, idiopathic Parkinson’s disease, cognitive and motor impairment.
10.Subjects who are on active treatment with drugs that are known to interact with paliperidone.
11.Have a history of alcohol or drug-dependence as per DSM-V criteria during the 6-month period immediately prior to screening.
12.Subjects with clinically significant laboratory investigations as per the investigator’s judgment.
13.Attempted suicide within 12 months before screening or are at imminent risk of suicide or violent behaviour as clinically assessed by the investigator.
14.Treatment with any of the following therapies:
•Injection of risperidone long acting injection within 6 weeks before screening.
•Electroconvulsive therapy within 3months prior to screening.
•Clozapine within 3 months before screening.
•Nonselective or irreversible monoamine oxidase inhibitor (MAOI) antidepressants within 30 days before screening.
•Other antidepressant agents, unless subject had been on a stable dose for at least 3 months before screening and plans on remaining on that same exact regimen for the entire duration of the study.
•Mood stabilizers, including lithium and all anticonvulsants, beta-blockers, and anti-parkinsonian medication. Unless subjects on a stable dose for at least 3 months before screening and expect to remain on that same exact regimen throughout the duration of the study.
15.Subjects who are:
•Pregnant
•Breast feeding
•Male or female of childbearing potential unwilling to use adequate methods of contraception throughout the study.
•Subjects whom 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.
•Subjects with known positivity for human immunodeficiency virus (HIV), HBsAg or HCV.
16.Participation in any interventional clinical study within the past 90 days of randomization.
17.History of difficulty with donating blood or difficulty in accessibility of veins.
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 evaluate the bioequivalence of Mylan’s Paliperidone Palmitate extended-Release Injectable Suspension with Janssen’s INVEGA SUSTENNA® in subjects with schizophrenia.
After 24 Week ( post dose 6 total 19 PK sample assessment )
Secondary Outcome
Outcome
TimePoints
To evaluate the safety and tolerability of Paliperidone Palmitate Extended-Release Injectable Suspension of Mylan Laboratories Limited, India in subjects with schizophrenia.
To evaluate the safety and tolerability of Paliperidone Palmitate Extended-Release Injectable Suspension of Mylan Laboratories Limited, India in subjects with schizophrenia.
Target Sample Size
Total Sample Size="264" Sample Size from India="264" Final Enrollment numbers achieved (Total)= "267" Final Enrollment numbers achieved (India)="267"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
The study is Randomized, Multicenter,
Multiple-dose, Two-treatment, Single-period, Parallel, Steady State
Bioequivalence Study of Paliperidone Palmitate Extended-Release Injectable
Suspension in Subjects with Schizophrenia under Fasting Condition.
This study will be initiated only after
obtaining the approvals of Institutional Ethics Committee (IEC) and clinical
trial permission from the Drug Controller General of India (DCGI). The subjects
qualifying inclusion and exclusion criteria will be invited to participate in
this study.
The recruitment will happen as per
randomization schedule. Subject will be randomized in a 1:1 ratio to Test or
Reference product.
Subject will
receive either Mylan’s paliperidone palmitate extended-Release Injectable
suspension or Janssen’s INVEGA SUSTENNA® as per the randomization. Main
conclusion on the bioequivalence will be drawn based on the PK data obtained
during last dosing interval.
Plasma concentrations of Paliperidone will
be measured by using a validated method.
Statistical analysis of pharmacokinetic
parameters comparing test and reference products will be performed to assess
bioequivalence.