CTRI/2024/02/062550 [Registered on: 12/02/2024] Trial Registered Prospectively
Last Modified On:
10/06/2024
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Other
Public Title of Study
Two-treatment Bioequivalence Study of Paliperidone Palmitate in adult schizophrenic patients
Scientific Title of Study
A Randomized, Open Label, Multicenter, Multiple Dose, Two Treatment, Two Period, Two Way, Crossover, Steady State Bioequivalence Study Between Paliperidone Palmitate Extended Release Intramuscular Injectable Suspension 156 mg per mL of Eugia Pharma Specialities Limited, India and INVEGA SUSTENNA Paliperidone Palmitate Extended Release Intramuscular Injectable Suspension 156 mg per mL Manufactured for Janssen Pharmaceuticals, Inc Titusville, NJ 08560, USA in Adult Patients with Schizophrenia or Schizoaffective Disorder.
Clinical Research Unit, Basement No 7 , Subburaman street Gandhi Nagar Madurai - 025020 Madurai TAMIL NADU
9443772233
vikhram@ahanahospitals.in
Dr G Prasad Rao
Asha Hospital
Clinical Research Room, Road no 14, Banjara Hills, Hyderabad 500034 Hyderabad TELANGANA
9985900005
prasad40@gmail.com
Dr Mahesh Bhirud
Ayush Multispeciality Hospital
Clinical Research Room, Ayush Multispeciality Hospital, Surya Arcade, 2nd Floor, Opp, Nimani Bus stand, Panchavati, Nashik-422003 Maharashtra, India Nashik MAHARASHTRA
9890740104
drmgbhirud@gmail.com
Dr Pradeep Chaurasiya
Gangoshri Hospital
Clinical Research Room, Lane 4, Gurudham Colony Bhelupur Varansi - 221010 Varanasi UTTAR PRADESH
7232986712
pradeepatgangoshri@gmail.com
Dr Mohit Joshi
K J Multispecialty Hospital and Research center
Clinical Research Room, K J Hospital, 9 Square Commercial Complex, Near Zanzarda, Cross, Road Bypass Highway,362001, Junagadh GUJARAT
8511115255
dr.joshimohit@gmail.com
Dr Shrikant kiran Nimbhorkar
KIMS Kingsway Hospital
Clinical Research Room, 44, Near Kasturchand Park Kingsway Nagpur 440001 Nagpur MAHARASHTRA
8600877750
dr.shrikantnimbhorkar@gmail.com
Dr Nitin Dalaya
Lifepoint Multispeciality Hospital
Clinical Research Room, 145/Mumbai Bangalore Highway near Hotel sayaji wakad, Pimpri-Chinchwad, Maharashtra 411057 Pune MAHARASHTRA
9552503201
drndalaya@gmail.com
Dr Nehal shah
OHM Hospital
Clinical Research Room, OHM Hospital, 41-A Karmachari Nagar - 1 Opp Alkapuri Society Bhuyangdev Ghatlodiya Road Ahmedabad - 380061 Ahmadabad GUJARAT
9925049569
doctornehal@gmail.com
Dr Manik Bhise
Prena Hospital
Clinical Research Room,
G47, Town Center N-6, Connaught Place, Near Ganesh Temple and Varsha Inn Hotel Town Center Cidco, Aurangabad 431003 Aurangabad MAHARASHTRA
7887888865
drbhisemanikclinicaltrials@gmail.com
Dr Arpit Jani
Shiv orthopedic Hospital
Clinical Research Room, 205-7, 404-6 Avni plaza mini kankaria New dr house Naroda Ahmadabad GUJARAT
9725846075
janiarpitm@gmail.com
Dr Priti Vikas Bhute
Treat me Hospital
Clinical Research Room, plot no .7 Hindustan colony, Wardha road near sai mandir Samarth nagar East nagpur MH- 440015 Nagpur MAHARASHTRA
INVEGA SUSTENNA Paliperidone Palmitate Extended Release Intramuscular Injectable Suspension 156 mg per mL Manufactured for Janssen Pharmaceuticals, Inc Titusville, NJ 08560, USA
aliperidone Palmitate extended release injectable suspension for intramuscular use 156 mg per mL test or reference product will be administered intramuscularly in the deltoid or gluteal muscle of each participant on Day 1 day 29 57 85 113, day 141, 169, 197, 225 & 253 at clinical site.
Intervention
Paliperidone Palmitate extended-release intramuscular injectable suspension 156 mg per ml by Eugia Pharma Specialities Limited India
Paliperidone Palmitate extended release injectable suspension for intramuscular use 156 mg per mL test or reference product will be administered intramuscularly in the deltoid or gluteal muscle of each participant on Day 1 day 29 57 85 113, day 141, 169, 197, 225 & 253 at clinical site.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Male or non-pregnant, non-lactating females aged 18-65 years (both inclusive) having a documented clinical diagnosis of schizophrenia or schizoaffective disorder according to the PI evaluation and
Diagnostic and Statistical (DSM-V).
2. Participant is willing to participate for the entire study and adhere to the study protocol and committed
for required clinic visits and dosing.
3. Written informed consent for participation in the study by the participant and participant’s legally acceptable representative (LAR) and willing to adhere to protocol requirements.
4. Participants having BMI between less the or equal to 18.00 - 30.00 kg per m2 (Both inclusive) and at least 50 kg weight for male participants and 48 kg for female participants.
5. Participants who at screening are on stable regimen of oral Paliperidone or Risperidone therapy or who are already receiving Paliperidone palmitate 156 mg per mL (100 mg Paliperidone) extended-release intramuscular injectable suspension and who at randomization are receiving a stable regimen of 156 mg per mL (100 mg Paliperidone) of monthly paliperidone palmitate extended-release suspension (at least 3 doses) via the intramuscular route.
6. Participants who are clinically stable and not hospitalized for exacerbation of psychiatric symptoms for at least 3 months before randomization.
7. Participants having treatment response score of less than 4 (unchanged or worse and side-effects outweigh the therapeutic effects) as evaluated using Clinical Global Impression scale by investigator at both screening and Baseline visits.
8. Participants not having any significant diseases or clinically significant abnormal findings except schizophrenia or schizoaffective disorder during screening.
9. Adequate organ and bone marrow function at screening and randomization.
ExclusionCriteria
Details
1. Participants with known hypersensitivity and or intolerance to study drug or any other component of the
drug or intolerance to oral paliperidone or risperidone prior to screening.
2. Pregnant or participants with childbearing potential not practicing contraceptive or other barriers of contraception.
3. Participants with a history of Neuroleptic Malignant Syndrome (NMS) while on treatment with antipsychotics.
4. History or presence of clinically significant cardiovascular disease, especially known history of QT prolongation, congenital long QT syndrome, recent acute myocardial infarction, cardiac arrythmias or uncompensated heart failure.
5. Participants with the QT prolongation risk. QTC more than 450 ms in male, QTC more than 470 ms in female .
6. Participants with current or relevant history of psychiatric illness except schizophrenia.
7. Participants with clinically significant illnesses or participant that have had major surgery within 4 weeks prior to first dosing of IMP and stabilization (if applicable), or who have not recovered from prior major surgery.
8. Participants with concurrent condition of Parkinson disease (except for drug-induced extrapyramidal
syndrome). Participants with history or presence of tardive dyskinesia. Participants with cognitive and
motor impairment.
9. Participants with concomitant treatment with hepatic enzyme inhibitors (including fluoxetine or
paroxetine) or medications known to interact with study medication or stabilization dose (if applicable)
within 2 weeks of the first dose.
10. Treatment with any of the following therapies:
Injection of risperidone long-acting injection within 6 weeks before randomization.
Electroconvulsive therapy within 3 months prior to screening.
Clozapine within 3 months before screening
11. Presence of syncope or orthostatic hypotension (defined as systolic blood pressure decrease of at least 30 mmHg or a diastolic blood pressure decrease of at least 20 mmHg within one to three minutes of standing up).
12. Participants with uncontrolled hypertension (systolic BP more than 150 mmHg diastolic BP more than 100 mmHg).
Method of Generating Random Sequence
Stratified randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To establish Bioequivalence between Test and Reference product
A total of 50 blood samples each of 03 mL will be collected from each participant for PK assessment during the study as below:
Pre-dose: Dose 3, Dose 4 and Dose 5 of each period.
Post-Dose (after Dose 5): 6.00, 12.00, 24.00, 48.00, 72.00, 96.00, 120.00, 144.00, 168.00, 192.00, 216.00, 240.00, 264.00, 288.00, 312.00, 336.00, 360.00, 408.00, 456.00, 504.00, 576.00 and 672.00 hours after administration of 5th dose in each period.
Secondary Outcome
Outcome
TimePoints
To document the safety & tolerability of the patients exposed
to paliperidone palmitate intramuscular injections (test & reference products) in the study.
Screening, At each dosing, check in Day 0, Day 140, Day 112, & Day 252 & at each ambulatory visit & during EOS visit. However, additionally on dosing day 113 & 253 vitals (Body temperature, Blood pressure, Heart rate & Respiratory rate) will be measured 1 hour prior
to dosing & at 6.00, 12.00, 24.00, 48.00 hours post dose.
Target Sample Size
Total Sample Size="110" Sample Size from India="110" Final Enrollment numbers achieved (Total)= "110" Final Enrollment numbers achieved (India)="110"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
The study is planned to be conducted as two period cross over design in male and non pregnant female patients with schizophrenia or schizoaffective disorder who are on a stable regimen of oral Paliperidone or Risperidone therapy or who are already receiving stable regimen of Paliperidone palmitate 156 mg/mL (100 mg Paliperidone) extended release injectable suspension. Participants will be screened within 14 days prior to stabilization (day -14 to day -1 will be considered as screening period). Only those participants will be randomized for dosing who are already on Paliperidone palmitate 156 mg /mL (100 mg Paliperidone) extended-release injectable suspension every month therapy for at least 3 months.
Post Randomization, test or reference product will be administered intramuscularly in the deltoid or gluteal muscle of each participant on Day 1 day 29 57 85 113, day 141, 169, 197, 225 & 252 at clinical site.
After the study is completed (after last PK sample collection on Day 281), patients may be continued on their current dose of Paliperidone using an approved paliperidone product as prescribed by their clinicians.
(Administration shall be performed on alternating body sides (left and right) for each injection)