CTRI/2021/12/038783 [Registered on: 21/12/2021] Trial Registered Prospectively
Last Modified On:
26/09/2024
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Other
Public Title of Study
To assess blood concentration of Paliperidone Prolonged Release Injectable Suspension at different times in patients with Schizophrenia following single dose
Scientific Title of Study
A Randomized, Multicenter, Single-Dose, Two-Treatment, Single- Period, Parallel, Bioequivalence Study of Mylan’s Paliperidone Prolonged-Release Suspension for Injection, 25 mg and Janssen-Cilag’s Xeplion® Prolonged Release Suspension for Injection, 25 mg in Subjects with Schizophrenia.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
Protocol no. PALI-ISR-1004, Version 2.0 dated 04 August 2021
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Dharmesh Domadia
Designation
Vice President - Global Clinical Operations
Affiliation
Cliantha Research Limited
Address
Department Clinical Trials, Room no. 01, 1st floor,6, Arista@Eight, Corporate House, Near Satyam House, Behind Rajpath Club, Bodakdev
Ahmadabad GUJARAT 380054 India
Phone
079-66219555
Fax
079-66219549
Email
ddomadia@cliantha.com
Details of Contact Person Scientific Query
Name
Dr Ankesh Barnwal
Designation
Associate Director- I– Clinical Trial Medical Services
Affiliation
Cliantha Research Limited
Address
Department Clinical Trials, Room no. 01, 1st floor, 6, Arista@Eight, Corporate House, Near Satyam House, Behind Rajpath Club, Bodakdev
Ahmadabad GUJARAT 380054 India
Phone
079-66219500
Fax
079-66219549
Email
abarnwal@cliantha.com
Details of Contact Person Public Query
Name
Mr Deepak Chawla
Designation
Project Manager - Clinical Trials
Affiliation
Cliantha Research Limited
Address
Department Clinical Trials, 2nd floor,6, Arista@Eight, Corporate House, Near Satyam House, Behind Rajpath Club, Bodakdev
Ahmadabad GUJARAT 380054 India
Phone
079-66219500
Fax
079-66219549
Email
dchawla@cliantha.com
Source of Monetary or Material Support
Mylan Laboratories Limited, Prestige Tech Park II, Varthur Hobli, Outer Ring Road, Kadubeesanahalli, Bengaluru-560 103, India
Primary Sponsor
Name
Mylan Laboratories Limited
Address
Prestige Tech Park II, Varthur Hobli, Outer Ring Road, Kadubeesanahalli, Bengaluru-560 103, India
Paliperidone Prolonged-release Suspension for Injection, 25 mg (Equivalent to 39 mg of paliperidone palmitate)
Single dose
Comparator Agent
Xeplion® Prolonged-release Suspension for Injection, 25 mg (Equivalent to 39 mg Paliperidone Palmitate)
Single dose
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
Subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified:
1. Patients having a clinical diagnosis of schizophrenia as per DSM V
2. Subjects who are clinically stable with no hospitalizations for exacerbation of psychiatric symptoms.
3. Patients with established tolerability and responsiveness to oral paliperidone/risperidone or injectable paliperidone prior to screening
4. Male or non-pregnant, non-lactating female subjects between 18 and 65 years of age (both inclusive)
5. Weight: Each subject is required to weigh at least 50 kg (110 lbs) for men and 48 kg (106 lbs) for women and have a Body Mass Index (BMI) value less than or equal to 35.0 kg/m2 but greater than or equal to 18.0 kg/m2
ExclusionCriteria
Details
Subject candidates must not be enrolled in the study if they meet any of the following criteria:
1. Institutionalized subjects.
2. Subjects with history of alcohol or drug-dependence as per DSM-V criteria.
3. Subjects with Ingestion of any alcoholic beverage within the 24 hours prior to the initial administration of study medication.
4. Subjects with ingestion of risperidone long-acting injection
5. Subjects with depot injection or implant of any drug other than hormonal contraceptive or hormone replacement therapy
6. Subjects currently being treated with Clozapine, monoamine oxidase inhibitor (MAOI) antidepressants, electroconvulsive therapy
7. Use of any medication, herbal supplement, or vitamin known to induce or inhibit hepatic enzyme activity
8. Subjects with dementia related psychosis
9. Subjects with Clinical Global Impression - Severity of illness (CGI-S) score of 5 or more
10. Subjects with suicidal ideation
11. Subjects with a history of Neuroleptic Malignant Syndrome (NMS)
12. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, genitourinary, musculoskeletal disease, uncontrolled metabolic diseases, clinically significant laboratory results or malignancies by the Principal Investigator or Medical Sub-Investigator.
13. Use of drugs that prolong the QTc interval,
14. Subjects with positive HIV, hepatitis B antigen, hepatitis C antibody, RPR or VDRL test
15. Subjects with positive urine drug screen
16. Subjects with history or presence of tardive dyskinesia, seizures idiopathic Parkinson’s disease, cognitive and motor impairment.
17. Subjects with donation or loss of blood or plasma
18. Subjects with participation in any interventional clinical study
19. Subjects with allergy or hypersensitivity to paliperidone, risperidone, other related products, or any inactive ingredients
20. Subjects has clinical signs and symptoms consistent with COVID-19 or had severe COVID-19
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To evaluate the bioequivalence of Mylan’s Paliperidone Prolonged-release Suspension for Injection 25 mg of Mylan Laboratories Limited, India with Janssen-Cilag’s Xeplion® 25 mg (equivalent to 39 mg Paliperidone Palmitate) in subjects with schizophrenia.
After 1st dose (Day 1) till day 140’
Secondary Outcome
Outcome
TimePoints
To evaluate the safety and tolerability of Mylan’s Paliperidone Prolonged-release Suspension for Injection, 25 mg in subjects with schizophrenia.
Safety will be assessed throughout the study, i.e., from signing of ICF to end of study visit (Day 140)
Target Sample Size
Total Sample Size="212" Sample Size from India="212" Final Enrollment numbers achieved (Total)= "217" Final Enrollment numbers achieved (India)="217"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
A Bioequivalence
Study with Mylan’s Paliperidone Prolonged-Release Suspension for Injection, 25
mg in Subjects with Schizophrenia with following objectives:
To evaluate the
bioequivalence of Mylan’s Paliperidone Prolonged-release Suspension for
Injection 25 mg of Mylan Laboratories Limited, India with Janssen-Cilag’s
Xeplion® 25 mg (equivalent to 39 mg Paliperidone Palmitate) in subjects with
schizophrenia.
To evaluate the safety and tolerability of
Mylan’s Paliperidone Prolonged-release Suspension for Injection, 25 mg in
subjects with schizophrenia.