CTRI/2018/09/015774 [Registered on: 20/09/2018] Trial Registered Prospectively
Last Modified On:
29/07/2022
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
A study to compare drug levels in blood of two formulations of a long acting injection of the drug Risperidone after administration in patients with Schizophrenia
Scientific Title of Study
A Randomized, Open Label, Two-Period, Two-Treatment, Two-Sequence, Multiple Dose, Crossover, Multicenter, Steady State Bioequivalence Study of Risperidone Long Acting Injection 25 mg/vial of Mylan Laboratories Limited, India with RISPERDAL CONSTA® (Risperidone) 25 mg/vial of Janssen Pharmaceuticals, Inc., USA in Subjects with Schizophrenia under Fasting Condition.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
CRL011712, Version 1.0, dated 07-Nov-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
Cliantha Research Limited, Garden View Corporate House No. 8 Opp. AUDA Garden,
Bodakdev, Ahmedabad-380054 Gujarat, India
Department of Psychiatry, 3rd floor, Room No-11 Subburam street, Gandi nagar, Madurai-625020, Tamilnadu, India Madurai TAMIL NADU
9843255444
Dr.ramasubramanian@gmail.com
Dr Timir Shah
Divyam Hospital
Department of Psychiatry, Clinical research Room-2nd Floor, Block No. 84, Palsana Cross Road, N. H. No. 8, Palsana, Surat – 394315, Gujarat, India Surat GUJARAT
9825137443
drtcshah@gmail.com
Dr Rajendra Anand
Kanoria Hospital & Research Centre
Room No. 301 (Clinical Research Room),
Airport - Gandhinagar Highway, Village - Bhat, Gandhinagar – 382428, Gujarat, India
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 Mahesh Chudgar
MITR Foundation
Department of Psychiatry,1st Floor,1 Shanti Nagar Society, Way to CCD Gully, Usmanpura, Ashram Road, Ahmedabad – 380013, Gujarat, India Ahmadabad GUJARAT
9825412109
mahesh_mitr@yahoo.co.in
Dr Radhika Reddy
Old Govt. General Hospital
(Associated with Govt. Siddhartha Medical College), Department of Psychiatry, Hanumanpet, Two Town, Vijayawada- 520002, Andhra Pradesh, India Krishna ANDHRA PRADESH
9848229798
rrvemireddy@yahoo.com
Dr Nehal Shah
Panchshil Hospital
Department of Psychiatry, 2nd Floor, New Sabarmati Railway Station, Ahmedabad – 380005, Gujarat, India Ahmadabad GUJARAT
9925049569
doctornehal@gmail.com
Dr Vaishal Vora
Ratnadeep Multispecialty Hospital
Department of Psychiatry, 5th Floor, Nakshtra Complex, Above HDFC bank, Maninagar Cross Road, Maninagar, Ahmedabad – 380008, Gujarat, India Ahmadabad GUJARAT
Ethics Committee, Radianz Health Care and Research, Ahana Hospital, No. 11. Subburaman Street, Gandhi Nagar, Anna Bus Stand , Madurai-625020, Tamilnadu, India
Institutional Ethics Committee, Divyam Hospital, Block No. 83, Palsana Cross Road, N. H. No. 8, Palsana, Surat - 394315, Gujarat, India
Approved
Institutional Ethics Committee, Siddhartha Medical College & Govt. General Hospital (IEC SMC & GGH), Govt. Siddhartha Medical College Campus, Ring Road, Gunadala, Vijayawada - 520008, Andhra Pradesh, India
Approved
Kanoria Ethics Committee, Kanoria Hospital & Research Centre, Airport – Gandhinagar Highway, Village – Bhat, Gandhinagar – 382428, Gujarat, India
Approved
LPR Ethics Committee, Lifepoint Multispecialty Hospital Pvt.Ltd, 145/1, Mumbai Bangalore Highway, Near Hotel Sayaji, Wakad, Pune – 411057, Maharashtra, India
RISPERDAL CONSTA® (Risperidone) 25 mg /vial of Janssen Pharmaceuticals, Inc., USA
RISPERDAL CONSTA® (Risperidone Long Acting Injection) 25 mg /vial
Administration: IM: 14 days cycle. Study treatment period: 12 weeks
Intervention
Risperidone Long Acting Injection 25 mg/vial of Mylan Laboratories Limited, India
Risperidone Long Acting Injection 25 mg /vial
Administration: IM: 14 days cycle. Study treatment period: 12 weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
Male or non-pregnant, non-lactating female between 18 and 65 years of age (inclusive).
Diagnosed with schizophrenia
Subjects with stable psychiatric symptoms as judged by the investigator/sub-investigator at the time of giving informed consent.
Currently stable on a regimen consisting of risperidone long-acting injection as judged by the Principal investigator/Medical Sub-investigator prior to randomization.
Subjects with adequate renal function defined as creatinine clearance (Cockcroft-Gault Equation) more than or equal to 80 mL/min
Adequate hematological parameters at screening and randomization
Adequate hepatic function at screening and randomization
The subject and LAR must demonstrate adequate decision-making ability in order to make an informed choice about participating in this study by providing written informed consent.
Agree to comply with the visit schedule and other requirements of the study.
ExclusionCriteria
Details
Known or suspected allergy or hypersensitivity to risperidone, paliperidone or similar drugs or other constituents of the formulation.
Diagnosis of alcohol or substance abuse as per DSM-V criteria during the 6-month period immediately prior to screening.
Any changes in antipsychotic medication or dosage during the past eight weeks prior to the first dose in Study Period I.
Relevant history or current presence of any significant or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular disease, organic mental disorder), renal, hepatic, hematologic, endocrine, immunologic, or other systemic disease.
History of uncontrolled diabetes, significant orthostatic hypotension uncontrolled hypertension, Parkinson’s disease, mood disorders or seizure disorder.
Subjects with dementia related psychosis.
Hospitalization due to exacerbation of psychiatric symptoms during the 3 months before screening.
Subjects with clinically significant hyperprolactinemia or with possible prolactin dependent tumor.
Subjects with blood dyscrasias.
Received Electroconvulsive Therapy (ECT) within the last 3months prior to screening.
Subjects with Clinical Global Impression - Severity of illness (CGI-S) score of 5 or more.
Any acute unstable or significant concomitant medical illness.
Subjects who are on active treatment with drugs that are known to interact with risperidone.
History of neuroleptic malignant syndrome or tardive dyskinesia.
Attempted suicide within 12 months before screening or are at imminent risk of suicide or violent behavior as clinically assessed by the investigator.
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
Subjects who are:
• Pregnant.
• Breast feeding
• Male or female of childbearing potential unwilling to use adequate method of contraceptive precautions throughout the study.
• Subject whom had major surgery within 4 weeks prior to study entry, 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
Subjects with clinically significant laboratory investigations as per the investigator’s judgment.
Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Sub-Investigator, could contraindicate the subject’s participation in this study.
Participation in any interventional clinical study within the past 90 days prior to study entry.
History of difficulty with donating blood or difficulty in accessibility of veins.
Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product in the study.
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 risperidone long acting injection 25 mg/vial of Mylan Laboratories Limited, India with RISPERDAL CONSTA®(risperidone) 25 mg/vial of Janssen Pharmaceuticals, Inc., USA in subjects with schizophrenia.
Not Applicable
Secondary Outcome
Outcome
TimePoints
To evaluate the safety and tolerability of risperidone long acting injection 25 mg/vial of Mylan Laboratories Limited, India in subjects with schizophrenia.
Safety will be evaluated throughout the study starting from the signing of informed consent form and till 28 (± 2) days after the last sample collection (Safety follow-up).
Target Sample Size
Total Sample Size="88" Sample Size from India="88" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
A bioequivalence study with risperidone in subjects with schizophrenia..
This study includes:
Screening period: Male and non-pregnant female subjects with schizophrenia will be eligible for the screening procedure. A written informed consent will be obtained prior to initiating screening procedures.
Treatment period: Subjects will be randomized to receive either Mylan’s Risperidone Long Acting Injection 25 mg/vial or Janssen’s RISPERDAL CONSTA® (Risperidone) 25 mg/vial as intramuscular injection as per randomization schedule (either the test or reference product) in a crossover design. Subject will receive each product in a cross-over fashion Subject will be randomized in a 1:1 ratio to one of the 2 sequences (TR or RT).
Main conclusion on the bioequivalence will be drawn based on the PK data obtained during last dosing interval. Plasma concentrations of risperidone will be measured by a using validated method at Mylan Laboratories Limited.
Statistical analysis of pharmacokinetic parameters comparing test and reference products will be performed to assess bioequivalence.