CTRI/2020/05/025244 [Registered on: 19/05/2020] Trial Registered Prospectively
Last Modified On:
17/03/2021
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Study of Paliperidone Palmitate injection 156mg/mL with INVEGA SUSTENNA® Injectable Suspension 156mg/mL in subjects with schizophrenia.
Scientific Title of Study
A multicenter, open label, balanced, randomized, two-treatment, single-period, parallel, steady-state bioequivalence study of Paliperidone Palmitate injection 156mg/mL of Qilu Pharmaceuticals Co., Ltd. with INVEGA SUSTENNA® (Paliperidone Palmitate) ER Injectable Suspension 156mg/mL of Janssen Pharmaceuticals, Inc. Titusville, NJ 08560 in subjects with schizophrenia.
Trial Acronym
NA
Secondary IDs if Any
Secondary ID
Identifier
CBCC/2019/004, Version 1.0 dated 01/May/2019
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Department of Psychiatry, Asarwa, Ahmedabad - 380016, Gujarat, India. Ahmadabad GUJARAT
9825718698
drminakshiparikh@gmail.com
Dr Mahesh Bhirud
Dhadiwal Hospital
1st Floor, Dhadiwal Hospital In coalition with shreeji health care, Opposite new CBS (thakker’s buzrr), Trambak Road, Nashik-422002, Maharashtra, India.
Nashik MAHARASHTRA
9890740104
drmgbhirud@gmail.com
Dr Timirkumar Shah
Divyam Hospital
3rd Floor, Block No 84, Palsana Cross Road, N.H. 8, Palsana, Surat- 394315, Gujarat, India.
Surat GUJARAT
9825137443
drteshah@gmail.com
Dr Manish Thakre
Government medical college & Hospital
2nd Floor, Department of Psychiatry, Medical Square, Near Hanuman Nagar, Nagpur-440003, Maharashtra, India.
Nagpur MAHARASHTRA
9850977266
drmanishthakre@gmail.com
Dr Sathyanarayana Rao T S
JSS Medical College Hospital
No. 1111, First Floor, B-Wing, M.G Road, Mysore- 570004,
Karnataka, India.
Mysore KARNATAKA
9845282399
tssrao19@yahoo.com
Dr Masthi Diwakar
Medstar Speciality Hospital
641/17/1/3, Kodigehalli Main Road, Sahakar Nagar,
Bangalore- 560092, Karnataka, India.
Bangalore KARNATAKA
9618942112
medstarclinicalresearch@gmail.com
Dr Tarak Shah
MITR Foundation
1st floor, 1 Shantinagar Society, Way to CCD Gully, Ashram Road, Usmanpura
Ahmedabad – 380013, Gujarat, India.
Ahmadabad GUJARAT
9824096430
tarak_mitr@yahoo.co.in
Dr Kulkarni Krishnaji Siddo
Oyster & Pearl Hospitals (Phandis Clinic Pvt. Ltd.)
4th Floor, 1671-75, Room no. 504, Ganeshkhind Rd,
Shivajinagar, Pune-411005, Maharashtra, India.
Pune MAHARASHTRA
9881009275
omksk54@gmail.com
Dr Vinod Kumar Goyal
Parth Hospital
2nd floor, college road, desai vago, near Basundiwala School, Nadiad-387001, Gujarat, India. Kheda GUJARAT
9824048232
drvgo999@gmail.com
Dr Vora Vaishal
Ratandeep Multispecialty Hospital
5th Floor, Nakshatra Complex, Above HDFC Bank, Maninagar Cross Roads, Maninagar,
Ahmedabad – 380008, Gujarat, India.
Ahmadabad GUJARAT
9825440891
vnvora@gmail.com
Dr Rakesh Kumar
Sardar Patel Medical College & AG of Hospitals
Ground Floor, Department of Psychiatry, DIMHANS, Sardar Patel Medical College & AG of Hospitals
Bikaner- 334003, Rajasthan, India.
Bikaner RAJASTHAN
9828812221
dr.rkgarhwal@gmail.com
Dr Ashok Goyal
Sardarmal Khandaka Memorial Hospital
Ground Floor, Kalwar Road, Hathoj, Jaipur-302012, Rajasthan, India. Jaipur RAJASTHAN
9413343445
ashokgoyaldr@yahoo.com
Dr Ramashanker Yadav
Shivam Hospital
C-4, Satyanarayan Society, Near Gor’s Kuvo, Near Jashoda Nagar Cross Road,
Jashoda Nagar, Ahmedabad – 382 445, Gujarat, India.
Ahmadabad GUJARAT
8264049261
yadavramashanker@gmail.com
Dr Buch Bakul Chandrakant
Shri Hatkesh Healthcare Foundation
Saraswati mandir Complex, Near Bhutnath Temple, College Road, Junagadh-362001, Gujarat, India. Junagadh GUJARAT
9825220330
bakulbuch@gmail.com
Dr Sathianathan Ramanathan
Sri Ramachandra Institute of Higher Education & Research [SRIHER]
Porur, Chennai- 600116, Tamil Nadu, India. Chennai TAMIL NADU
9841019910
sathianathen6@yahoo.com
Dr Nakul Vanjari
Sujata Birla Hospital & Medical Research Centre
Opposite Bytco College, Nashik Pune Highway, Nashik Road, Nashik- 422101, Maharashtra, India. Nashik MAHARASHTRA
INVEGA SUSTENNA® (Paliperidone Palmitate) ER Injectable Suspension 156mg/mL of Janssen Pharmaceuticals, Inc. Titusville, NJ 08560 in subjects with schizophrenia.
Dose: 156 mg. Frequency: Once in 28 Days, Route of Administration: intramuscular, Duration of Therapy: 6 Dose
Intervention
Paliperidone Palmitate injection 156mg/mL of Qilu Pharmaceuticals Co., Ltd.
Dose: 156 mg. Frequency: Once in 28 Days, Route of Administration: intramuscular, Duration of Therapy: 6 Dose
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Willing and able to provide voluntary informed consent and to follow the protocol requirements.
2. Subject aged 18-65 years (both inclusive) having body mass index (BMI) between 17.00 and 30.00 (both inclusive) calculated as weight in kg/height in m2.
3. Subjects with diagnosis of schizophrenia as per DSM-IV-TR criteria or later.
4. Subjects receiving Paliperidone long-acting injection at a dose of 156mg/mL via the intramuscular route and have completed at least 2 doses prior to randomization.
5. Acceptable hematology status:
a. Hemoglobin more than or equal to 9 g/dL
b. Absolute neutrophil count (ANC) more than or equal to 1500 cells / microlitre
c. Platelet count more than or equal to 100,000 cells/ microliter
6. Acceptable liver function:
a. Alanine aminotransferase (ALT) less than or equal to 2X upper limit of normal (ULN)
b. Aspartate aminotransferase (AST) less than or equal to 2X ULN
c. Bilirubin less than 1.2 mg/dL
d. Alkaline phosphatase less than or equal to 2X ULN
7. Subjects with creatinine clearance more than or equal 80 mL/minute.
8. Female subjects with negative serum pregnancy test at screening.
9. Females of child bearing potential must be willing to use adequate contraception (as defined below) throughout the study and continuing for at least 3 months after the last dose of the investigational product. For this study, acceptable and effective methods of contraception for females include:
a. Intrauterine device placed at least 3 months prior to the start of the study and remaining in place during the study period,
b. Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide plus a male or female condom) or
c. Absolute sexual abstinence (no sexual intercourse or genital contact with a male partner).
10. For male subjects, one of the following must apply in order to avoid impregnating a female partner, from the first study dose and agree to follow throughout the study and for at least 3 months following the last dose of the study.
a. Absolute sexual abstinence (no sexual intercourse or genital contact with a female partner).
b. Use of barrier method with spermicide
11. No history of addiction to any recreational drug or drug dependence or alcohol addiction.
ExclusionCriteria
Details
1. Hypersensitivity to paliperidone palmitate or risperidone or to any of the excipients.
2. Have current thoughts of suicide (suicidal ideation) or violent tendencies at the time of screening.
3. History or presence of neuroleptic malignant syndrome (NMS), tardive dyskinesia, dementia-related psychosis, Parkinson’s disease or epilepsy/seizures.
4. Subjects on different antipsychotic treatment.
5. Subjects with congenital long QT syndrome.
6. Subjects with history of arrhythmia.
7. Subjects with positive urine screen for Drug of Abuse. (Except for benzodiazepine which is a permissible medication supported by prescription)
8. Uncontrolled clinically significant major cardiac, liver or kidney disease, diabetes mellitus etc.
9. Smokers who smokes greater than or equal to 10 cigarettes or equivalent per day.
10. Any clinically significant abnormal laboratory parameter evaluated during screening.
11. Subjects with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
12. Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study that would limit adherence to study requirements.
13. Participation in any clinical study within 90 days before the first Investigational Product administration.
14. Donation and/or loss of more than or equal to 350 mL (1 unit) of blood within 90 days prior to first dose of Investigational Product for the current study.
15. Lactating women.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To assess the steady-state bioequivalence of Paliperidone Palmitate injection 156mg/mL of Qilu Pharmaceuticals Co., Ltd. with INVEGA SUSTENNA® (Paliperidone Palmitate) ER Injectable Suspension 156mg/mL of Janssen Pharmaceuticals, Inc. Titusville, NJ 08560 in subjects with schizophrenia.
The IP will be administered on Day 1, 29, 57, 85, 113 and 141 of the study at study site.Prior to dosing on day 85 (Pre-dose blood sample), 113 (Pre-dose blood sample), 141 (Pre-dose blood sample (00.00) hours) & Post dose 8 hours & on day 142 (24 hours), 143 (48 hours), 144 (72 hours), 145 (96 hours), 146 (120 hours), 147 (144 hours), 148 (168 hours), 151 (240 hours), 154 (312 hours), 157 (384 hours), 160 (456 hours), 163 (528 hours), 166 (600 hours) & 169 (672 hours)
Secondary Outcome
Outcome
TimePoints
To monitor the adverse events and to ensure the safety of subjects.
The IP will be administered on Day 1, 29, 57, 85, 113 and 141 of the study at study site.Prior to dosing on day 85 (Pre-dose blood sample), 113 (Pre-dose blood sample), 141 (Pre-dose blood sample (00.00) hours) & Post dose 8 hours & on day 142 (24 hours), 143 (48 hours), 144 (72 hours), 145 (96 hours), 146 (120 hours), 147 (144 hours), 148 (168 hours), 151 (240 hours), 154 (312 hours), 157 (384 hours), 160 (456 hours), 163 (528 hours), 166 (600 hours) & 169 (672 hours)
Target Sample Size
Total Sample Size="240" Sample Size from India="240" 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
This is a multicenter, open label, balanced, randomized, two-treatment, single-period, parallel, steady-state bioequivalence study of Paliperidone Palmitate injection 156mg/mL of Qilu Pharmaceuticals Co., Ltd. with INVEGA SUSTENNA® (Paliperidone Palmitate) ER Injectable Suspension 156mg/mL of Janssen Pharmaceuticals, Inc. Titusville, NJ 08560 in subjects with schizophrenia.
The Primary Objective is to assess the steady-state bioequivalence of Paliperidone Palmitate injection 156mg/mL of Qilu Pharmaceuticals Co., Ltd. with INVEGA SUSTENNA® (Paliperidone Palmitate) ER Injectable Suspension 156mg/mL of Janssen Pharmaceuticals, Inc. Titusville, NJ 08560 in subjects with schizophrenia
The Secondary Objective is to monitor the adverse events and to ensure the safety of subjects
The 90% confidence interval of the relative mean Cmaxss and AUC(Tau) of the test to reference formulation for Ln-transformed data should be within 80.00% to 125.00% for Paliperidone to establish bioequivalence for those subjects who achieves the steady state.