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CTRI Number  CTRI/2018/12/016671 [Registered on: 13/12/2018] Trial Registered Prospectively
Last Modified On: 28/06/2021
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   Pharmocokinetic Study of Aripiprazole Extended Release Injectable Suspension in patients with Schizophrenia 
Scientific Title of Study   A Randomized, Multicenter, Multiple-dose, Crossover, Steady-state, Bioequivalence Study of Aripiprazole Extended Release Injectable Suspension and Abilify Maintena® in Subjects with Schizophrenia 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dharmesh Domadia 
Designation  Associate Vice President - Global Clinical Operation 
Affiliation  Cliantha Research Limited 
Address  Garden View Corporate House No. 8 Opp. AUDA Garden, Bodakdev, Ahmedabad 380054 Gujarat, India

Ahmadabad
GUJARAT
380054
India 
Phone  9879590828  
Fax  0796613549  
Email  ddomadia@cliantha.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Ankesh Barnwal 
Designation  Assistant General Manager - Medical Services 
Affiliation  Cliantha Research Limited 
Address  Garden View Corporate House No. 8 Opp. AUDA Garden, Bodakdev, Ahmedabad 380054 Gujarat, India

Ahmadabad
GUJARAT
380054
India 
Phone  9909019497  
Fax  0796613549  
Email  abarnwal@cliantha.in  
 
Details of Contact Person
Public Query  
Name  Mr Foram Madhu 
Designation  Project Manager 
Affiliation  Cliantha Research Limited 
Address  Garden View Corporate House No. 8 Opp. AUDA Garden, Bodakdev, Ahmedabad 380054 Gujarat, India

Ahmadabad
GUJARAT
380054
India 
Phone  9712915985  
Fax  0796613549  
Email  fmadhu@cliantha.in  
 
Source of Monetary or Material Support  
Mylan Laboratories Limited. Bilekahalli, Bannerghatta Road, Bangalore 560076, India. 
 
Primary Sponsor  
Name  Mylan Laboratories Limited 
Address  Bilekahalli, Bannerghatta Road, Bangalore 560076, India.  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr P N Suresh Kumar  IQRAA Psychiatry Care & Rehabilitation Centre  IQRAA International Hospital & Research Centre, Department of Psychiatry Ground Floor, Civil Station (P.O.), Ernaqualam, Kozhikode, Kerala - 673020
Kozhikode
KERALA 		 9447218825

drpnsuresh@gmail.com 
Dr Sathyanarayana Rao TS  JSS Medical College & Hospital   Room No 1111, First Floor, B Wing, Department of Psychiatry, M.G. Road, Mysore-570004
Mysore
KARNATAKA 		 9845282399

tssrao19@yahoo.com 
Dr Ratnakar Inamdar  Medipoint Hospital Pvt. Ltd.  Department of Psychiatry 3rd floor, 241/1 , New D.P. Road, Aundh -Baner Boundary, Pune, 411007, Maharashtra
Pune
MAHARASHTRA 		 9372336885

drinamdar.pentagon@gmail.com 
Dr Mahesh Bhirud  Navsanjeevani Hospital Sankalp Speciality Healthcare Pvt. Ltd  Plot 8, Motkari Nagar, Behind Tupsakhare Lawns, Tidke Colony, Mumbai Naka Nashik - 422002
Nashik
MAHARASHTRA 		 9890740104

drmgbhirud@gmail.com 
Dr V Radhika Reddy  Old Govt. General Hospital (Associated with Govt. Siddhartha Medical College  Room No, 1, Ground Floor, Department of Psychiatry, Hanumanpet, Two Town, Vijayawada, Andhra Pradesh - 520002
Krishna
ANDHRA PRADESH 		 9848229798

rrvemireddy@yahoo.com 
Dr K S Kulkarni  Oyster & Pearl Hospitals  5th Floor 504, 1671-75, Ganeshkhind Road, Shivajinagar, Pune - 411005, Maharashtra, India
Pune
MAHARASHTRA 		 9822116995

Kulkarniks@hotmail.com 
Dr Sudhir Hebbar  Sapthagiri Institution of Medical Sciences and Research  Department of Psychiatry Ground floor, No. 15, Chikkasandra, Hesaragatta Main Road, Bangalore - 560090
Bangalore
KARNATAKA 		 9845133229

drsudhirhebbar@gmail.com 
Dr Ramashanker Yadav  Shivam Hospital   c/4, Room No, Ground Floor Department of Psychiatry, Satyanarayan soc, Gors kuva Jashodanagar, Maninagar (E) Ahmedabad
Ahmadabad
GUJARAT 		 8264049261

yadavramashanker@gmail.com 
Dr Bakul Buch  Shri Hatkesh Healthcare Foundation  Saraswati Mandir Complex, Near Bhutnath Temple, College Road, Junagadh 362001, Gujrat, India
Junagadh
GUJARAT 		 9825220330

bakulbuch@gmail.com 
Dr Amit Yeole  Supe Heart and Diabetes Hospital & Research Center  Department of Neurology Ground floor, Opp. Adhar ashram, Near Runtha School, Gharpura ghat, Ashok Stambh, Nashik-422002, Maharashtra
Nashik
MAHARASHTRA 		 7588554530

amit_yeole37@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Hatkesh Healthcare Foundation Ethics Committee  Approved 
Institutional Ethics Committee, Siddhartha Medical College and Gov General Hospital  Approved 
Institutional Ethics Committee, IQRAA International Hospital & Research Centre  Approved 
Institutional Ethics Committee, JSS Medical College & Hospital  Approved 
Institutional Ethics Committee, Sapthagiri Institute of medical sciences & research center  Approved 
Navsanjeevani Hospital Ethics Committee, Nashik  Approved 
O & P Institutional Ethics Committee, Oyster & Pearl Hospitals  Approved 
Penta-Med Ethics Committee  Approved 
Shivam Ethics Committee  Approved 
Supe Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F209||Schizophrenia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Abilify Maintena®Extended-Release Injectable Suspension, 400 mg single-dose vial Manufactured by Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan; Distributed and Marketed by Otsuka America, Pharmaceutical, Inc., Rockville, MD 20850 USA  Administration: IM: 30 days cycle  
Intervention  Aripiprazole Extended-Release Injectable Suspension, 400 mg single-dose vial Manufactured by: Mylan Laboratories Limited, India  Administration: IM: 30 days cycle  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Subjects must fulfill all the following inclusion criteria to be eligible for participation in the study:

1. Male or non-pregnant, non-lactating female subjects between 18 and 65 years of age (inclusive).
2. Documented diagnosis of schizophrenia
3. Subjects who are clinically stable and have had no hospitalization for exacerbation of psychiatric symptoms.
4. Currently stable on a regimen consisting of Aripiprazole Extended-Release Injectable Suspension
5. Subjects with established tolerability to oral Aripiprazole prior to screening
 
 
ExclusionCriteria 
Details  Subjects must not be enrolled in the study if they meet any of the following criteria:

1. Known or suspected allergy or hypersensitivity to aripiprazole or other constituents of the formulation.
2. History of medically significant adverse events or intolerance with aripiprazole based on investigator’s discretion.
3. Subjects who are on active treatment with drugs that are known to interact with Aripiprazole
4. Subjects with history or at risk of venous thromboembolism as per investigator’s discretion.
5. Subjects with poor GFR on screening.
6. Subjects with Clinical Global Impression – Severity of illness (CGI-S) score of 5 or more.
7. Subjects with inadequate muscle mass to receive the intramuscular injection according to the investigator.
8. Subjects with a history of Neuroleptic Malignant Syndrome (NMS) or tardive dyskinesia while on treatment with atypical antipsychotics.
9. Subjects with dementia related psychosis.
10. Subjects with history or presence of seizures or other conditions that potentially lower the seizure threshold.
11. Presence of significant orthostatic hypotension
12. Subjects with known cardiovascular disease cerebrovascular disease, uncontrolled Hyperglycemia/diabetes mellitus,.
13. History of drug induced leukopenia/ neutropenia/ agranulocytosis.
14. Subjects with abnormal hematological parameters at screening and randomization
15. Subjects with abnormal liver function tests at screening and randomization
16. History of alcohol or substance abuse during the 6-month period immediately prior to screening.
17. Participation in any interventional clinical study within the past 90 days of randomization.
18. Male or female of childbearing potential unwilling to use adequate methods of contraception throughout the study.
19. History of difficulty with donating blood or difficulty in accessibility of veins.
20. Donation of blood within 90 days prior to receiving the first dose of investigational medicinal product in the study.
21. Subject who had major surgery within 4 weeks prior to study entry, who have not recovered from prior major surgery, or who have surgery scheduled during the course of the study.
22. Subjects with known positivity for human immunodeficiency virus (HIV), HBsAg and/or HCV.
23. Subjects having any other clinically significant finding of the physical examination or laboratory value or any reason which, in the opinion of the investigator, would prevent the subject from safely participating in the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
“Evaluation of bioequivalence of Mylan’s Aripiprazole Extended-Release Injectable Suspension 400 mg with Abilify Maintena® (Aripiprazole) 400 mg of Otsuka Pharmaceutical Co., Ltd., Japan, in subjects with schizophrenia.”  540 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Safety assessment:
Safety assessments include measurement and monitoring of vital signs, physical examination, weight examination, injection site reaction assessment, evaluation of severity of illness by assessing Clinical Global Impression – Severity of illness (CGI-S) scale, adverse events assessment and clinical laboratory assessment.
 		 540 Days 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2019 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

A bioequivalence study with Aripiprazole long acting injection in subjects with schizophrenia with the following objectives.

To demonstrate the bioequivalence of Mylan’s Aripiprazole Extended-Release Injectable Suspension 400 mg with Abilify Maintena® (Aripiprazole) of Otsuka Pharmaceutical Co., Ltd., in subjects with schizophrenia.

To evaluate the safety and tolerability of Mylan’s Aripiprazole Extended Release Injectable Suspension in subjects with Schizophrenia.

 
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