| CTRI Number |
CTRI/2022/03/040709 [Registered on: 02/03/2022] Trial Registered Prospectively |
| Last Modified On: |
03/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Risperidone Long acting injection in patients with Schizophrenia. |
|
Scientific Title of Study
|
A randomized, multi-center, two-period, two-treatment, two-sequence, single dose, crossover, comparative bioavailability study of Mylan’s Risperidone Long-Acting Injection, 12.5 mg/vial with Janssen’s Risperdal Consta®, 12.5 mg/vial in Twenty-four patients with Schizophrenia under fasting condition. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RISP-IJD-1002, version 1.0 dated 02/Dec/2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandeep Singh |
| Designation |
Vice President – Clinical Operations |
| Affiliation |
CBCC Global Research |
| Address |
2nd Floor, Skoda House Opp. LJ Campus, S. G. Highway
Sarkhej, Ahmedabad - 382210, India.
Ahmadabad
GUJARAT
382210
India |
| Phone |
9637555304 |
| Fax |
|
| Email |
sandeep.singh@cbccusa.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Singh |
| Designation |
Vice President – Clinical Operations |
| Affiliation |
CBCC Global Research |
| Address |
2nd Floor, Skoda House Opp. LJ Campus, S. G. Highway
Sarkhej, Ahmedabad - 382210, India.
Ahmadabad
GUJARAT
382210
India |
| Phone |
9637555304 |
| Fax |
|
| Email |
sandeep.singh@cbccusa.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Singh |
| Designation |
Vice President – Clinical Operations |
| Affiliation |
CBCC Global Research |
| Address |
2nd Floor, Skoda House Opp. LJ Campus, S. G. Highway
Sarkhej, Ahmedabad - 382210, India.
Ahmadabad
GUJARAT
382210
India |
| Phone |
9637555304 |
| Fax |
|
| Email |
sandeep.singh@cbccusa.com |
|
|
Source of Monetary or Material Support
|
| Mylan Laboratories Limited, Bengaluru, India |
|
|
Primary Sponsor
|
| Name |
Mylan Laboratories Limited |
| Address |
9th Floor, Prestige Tech Park II,
Varthur Hobli, Outer Ring Road, Kadubeesanahalli, Bengaluru-560103, India
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| CBCC Global Research |
Second Floor Skoda House Opposite L J Campus S G Highway
Sarkhej, Ahmadabad-382210, GUJARAT,India |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harful S Bishnoi |
DIMHANS Sardar Patel Medical College |
DIMHANS Sardar Patel Medical College & AG of Hospitals,Bikaner– 334003, Rajasthan
Bikaner
RAJASTHAN |
9782300231
hsbishnoi@rediffmail.com |
| Dr Vinod Kumar Goyal |
Parth Hospital |
2 Floor , Hr. Busundiwala School, Paras Circle, College Round, Desai Vugo, Nadiad-387001
Kheda
GUJARAT |
9824048232
drvgo999@gmail.com |
| Dr Vaishal Vora Nareshchandra |
Ratandeep Multispeciality Hospital |
Nakshatra Complex, Above HDFC Bank, Maninagar cross road, Maninagar, Ahemdabad, Gujarat-380008, India
Ahmadabad
GUJARAT |
9825440891
vnvora@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTE RATANDEEP MULTI SPECIALITY HOSPITAL |
Approved |
| Ethics Committee, S.P.Medical College |
Approved |
| Institutional Ethics Committee-CHARUSAT Charotar University Of Science And Technology Nadiad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F209||Schizophrenia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Janssen’s Risperdal Consta® Injection, 12.5 mg/vial |
Intramuscular route, Single dose |
| Intervention |
Risperidone Long-Acting Injection, 12.5 mg/vial of Mylan Laboratories Limited |
Intramuscular route, Single dose |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having a clinical diagnosis of schizophrenia as per DSM V and on stabilized treatment with antipsychotic agents other than paliperidone or risperidone.
2.Patients with stable psychiatric symptoms as judged by the Investigator at the time of giving informed consent.
3.Patients with established tolerability to oral or injectable risperidone prior to dosing.
4.Male or non-pregnant, non-lactating female subjects
5.Patients must be between 18 and 65 years of age (inclusive)
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
1.Patients who are on active treatment with drugs that are known to interact with risperidone
2.Diseases:
a. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, genitourinary, musculoskeletal disease or malignancies unless deemed not clinically significant by the Investigator.
b. Parkinson’s disease, mood disorders, or seizure disorder.
c. Patients with dementia related psychosis.
d. Patients with clinically significant hyperprolactinemia or with possible prolactin dependent tumor.
e. Patients with blood dyscrasias.
f. Glomerular Filtration Rate (GFR) less than 60 ml per min as estimated using the Cockcroft-Gault equation.
3.Oral Risperidone and/or paliperidone and Risperidone long-acting injection within 3 months prior to study drug administration. Paliperidone palmitate injection - 1 month and 3 month product within 1 year and 18 months respectively prior to study drug administration.
4.Patients with score of 2 in two or more movements or a score of 3 or 4 in a single movement as per AIMS (Abnormal Involuntary Movement Scale)
5.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, including: bradycardia, cardiac arrhythmias, hypokalaemia or hypomagnesemia, concomitant use of other drugs that known to prolong the QTc interval
6.Allergy or hypersensitivity to risperidone, paliperidone, other related products, or any inactive ingredients.
7.Patients with confirmed novel coronavirus infection (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 PK bioequivalence of Mylan’s Risperidone Long-Acting Injection, 12.5 mg/vial with Janssen’s Risperdal Consta®, 12.5mg/vial in patients with schizophrenia under fasting conditions.
Assessed after Period 1 dosing through to Day 64 of Period 1 and after Period 2 dosing through to Day 64 of Period 2
|
In each period, patients will remain in the clinic from Day 1 (evening prior to
dosing) until Day 2 (24 hours after dosing) and PK samples will be collected on
Day 1 (pre-dose and at 1, 2, 4, 8, 12 hours) and on Day 2 (24 hours).
Patients will visit the site for ambulatory PK sample collection on Day 3, Day 5, Day 8, Day 11, Day 15, Day 18, Day 21, Day 24, Day 27, Day 30, Day 32, Day 34, Day 36, Day 38, Day 40, Day 43, Day 50, Day 57, and Day 64 in each period
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TTo evaluate the safety and tolerability of Mylan’s Risperidone Long-Acting Injection, 12.5 mg/vial in patients with schizophrenia. |
Safety will be assessed throughout the study i.e., from signing of ICF to end of study visit (Day 64 of period 2) |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/03/2022 |
| Date of Study Completion (India) |
02/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
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 Risperidone Long acting injection, 12.5mg/vial in subjects with schizophrenia with the following Objectives: To evaluate the PK bioequivalence of Mylan’s Risperidone Long-Acting Injection, 12.5 mg/vial with Janssen’s Risperdal Consta®, 12.5 mg/vial in patients with schizophrenia under fasting conditions. To evaluate the safety and tolerability of Mylan’s Risperidone Long-Acting Injection, 12.5 mg/vial in patients with schizophrenia. |