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CTRI Number  CTRI/2018/01/011521 [Registered on: 23/01/2018] Trial Registered Prospectively
Last Modified On: 16/03/2018
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   Study to prove bioequivalence of Risperidone prolonged-release susp. for Intra Muscular inj 25 mg/vial of Pharmathen S.A. Greece in adult schizophrenic patients who are on stable dose. 
Scientific Title of Study   A randomized, multi center, open label, balanced, two-treatment, two-period, two-sequence, multiple dose, crossover, steady-state bioequivalence study of Risperidone prolonged-release suspension for intramuscular injection 25 mg/vial of Pharmathen S.A., Greece in comparison with RISPERDAL CONSTA 25 mg powder and solvent for prolonged-release suspension for intramuscular injection of Manufactured by: Janssen Pharmaceutica N.V., Beerse, Belgium in adult schizophrenic patients who are already receiving Risperidone prolonged-release suspension for intramuscular injection 25 mg/vial. 
Trial Acronym  13 VIN 317 
Secondary IDs if Any  
Secondary ID  Identifier 
17-VIN-0317  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashoka Kumar Singh 
Designation  Head - Clinical Operations 
Affiliation  Veeda Clinical Research Pvt. Ltd. 
Address  Veeda Clinical Research Pvt. Ltd. Shivalik Plaza-A, Near IIM, Ambawadi

Ahmadabad
GUJARAT
380 015
India 
Phone  7930013000  
Fax  07930013010  
Email  Ashoka.Singh@veedacr.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Yogesh Patel  
Designation  Snr. Manager-Medical Monitor 
Affiliation  Veeda Clinical Research Pvt. Ltd. 
Address  Veeda Clinical Research Pvt. Ltd. Shivalik Plaza-A, Near IIM, Ambawadi

Ahmadabad
GUJARAT
380015
India 
Phone  7930013000  
Fax  7930013010  
Email  yogesh.ap@veedacr.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashoka Kumar Singh 
Designation  Head - Clinical Operations 
Affiliation  Veeda Clinical Research Pvt. Ltd. 
Address  Veeda Clinical Research Pvt. Ltd. Shivalik Plaza-A, Near IIM, Ambawadi

Ahmadabad
GUJARAT
380015
India 
Phone  7930013000  
Fax  7930013010  
Email  Ashoka.Singh@veedacr.com  
 
Source of Monetary or Material Support  
Pharmathen S.A. Dervenakion 6, 15351, Pallini, Athens, Greece  
 
Primary Sponsor  
Name  Pharmathen S A 
Address  Dervenakion 6 15351 Pallini Athens Greece Tel 302106604300 Fax 302106604583 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vishal Damani  Bodyline Hospitals  3rd floor, Opp. Annapurna Hall Nr. Dev Status New Vikas Gruh 380007 India
Ahmadabad
GUJARAT 		 07926640505
07926640558
drdamani14@yahoo.co.in 
Dr Radhika Reddy  Department of Psychiatry, Old Govt. General hospital,   anumanpeth, two town, Vijaywada, Andhra Pradesh, India.
Hyderabad
ANDHRA PRADESH 		 9848229798
0866-2450391
rrvemireddt@yahoo.com 
Dr Timir Shah  Divyam Hospital  Ground floor, Psychiatry department, Block No. 84 Palsana Cross Roads N.H. No. 8 Surat 394315 Gujarat India.
Surat
GUJARAT 		 9825137443

drtcshah@gmail.com 
Dr Rajendra Anand  Kanoria Hospital and Research Centre  Ground floor Airport Gandhinagar Highway Village Bhat Dist. Gandhinagar 382428 India
Gandhinagar
GUJARAT 		 07923969274
07923969452
drrajendraanand@yahoo.com 
Dr Kishore Dudani  Malpani Multispeciality Hospital  SP 6 Road No. 01 V.K.I. Area Sikar Road 302013 India.
Jaipur
RAJASTHAN 		 9887350168
1412333886
dudanikishoredr@gmail.com 
Dr Ratnakar Inamdar  Medipoint Hospital Pvt Ltd   Medipoint Hospital Pvt Ltd 241/1 New D.P.Road Aundh Baner Boundry Baner Road 411007 India
Pune
MAHARASHTRA 		 02028278081
02028278081
drinamdar.pentagon@gmail.com 
Dr Shreyas Magia  Meditrina Institute of Medical Science  278, Central Bazar Road, Ramdaspeth, Nagpur-440010, Maharashtra, India
Nagpur
MAHARASHTRA 		 9326886738

vijaya_bhakte1811@yahoo.co.in 
Dr Amar Shinde  Noble Hospital Pvt. Ltd  Psychiatry department, Pune - 153, Magarpatta City Road, Hadapsar 411013 India.
Pune
MAHARASHTRA 		 02066285000
02066285177
dramar79@gmail.com 
Dr Nikhil Pande  Orange city Hospital and Research Institute  1st floor, Room no. 9, 19, Pande Layout, 440015 India.
Nagpur
MAHARASHTRA 		 9225260606

vijaya_bhakte1811@yahoo.co.in 
Dr Vaishal Vora  Ratandeep Multispecialty Hospital  2nd Floor Nakshatra Complex Above HDFC Bank Maninagar Cross Road Maninagar 380008 India.
Ahmadabad
GUJARAT 		 079-25463963
079-30435000
vnvora@gmail.com 
Dr Nehal Shah  Sanjivani Super Speciality Hospital  Ground floor, Uday park soci. Nr. Sunrise park Vastrapur India
Ahmadabad
GUJARAT 		 07926300411
07926307165
doctornehal@gmail.com 
Dr Bakul Buch  Shri Hatkesh Healthcare Foundation  3rd Floor Clinical Research department, Saraswati Mandir Complex Near Bhutnath Temple College Road Junagadh 362001 India
Junagadh
GUJARAT 		 0285-2653652

bakulbuch@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
Bodyline Hospitals Institutional Ethics Committee  Approved 
Diyam Hospital Ethical Review Board Surat  Approved 
Ethics Committee Ratnadeep Multispeciality Hospital  Approved 
Hatkesh Healthcare Foundation Ethics Committee  Approved 
Institutional Ethics Committee Malpani Multispeciality Hospital  Approved 
Institutional Ethics Committee Orange City Hospital  Approved 
Institutional Ethics Committee Siddhartha Medical College and Government General Hospital  Approved 
Kanoria Ethics Committee Kanoria Hospital and Research Centre  Approved 
Meditrina Institute Ethics Committee  Approved 
Noble Hospital Institutional Ethics Committee  Approved 
Penta-Med Ethics Committee  Approved 
Sanjivani Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
No Objection Certificate 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Schizophrenia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  RISPERDAL CONSTA 25 mg powder and solvent for prolonged-release suspension for intramuscular injection, Manufactured by: Janssen Pharmaceutica N.V., Beerse, Belgium Imported, Packaged and Marketed by: Kohlpharma GmbH, 66663 Merzig, Germany  patient will receive his/her established maintenance dose of Risperidone 25 mg/vial prolonged-release suspension for injection via the intramuscular route every two weeks as per randomization schedule (either the test or reference product) in a crossover design at gluteal injection site for total of 4 doses in each period. The site of administration will be alternated between two buttocks in two subsequent doses in each period. 
Intervention  Risperidone prolonged-release suspension for intramuscular injection 25 mg/vial of Pharmathen S.A., Greece.   patient will receive his/her established maintenance dose of Risperidone 25 mg/vial prolonged-release suspension for injection via the intramuscular route every two weeks as per randomization schedule (either the test or reference product) in a crossover design at gluteal injection site for total of 4 doses in each period. The site of administration will be alternated between two buttocks in two subsequent doses in each period. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Adults (both inclusive) having clinical diagnosis of schizophrenia (as per DSM IV-TR or later).
2.Have body mass index of 18.5 to 30kg/m2.
3.Schizophrenic patients who are already receiving risperidone prolonged-release suspension for intramuscular injection 25 mg/vial every two weeks and who have received at least 3 doses of the same.
4.Adequate hematological parameters at screening defined by:
Total white blood cell count more than and equal to 4000/c.mm
ANC more than equal to 1500/mm3
Platelet count more than and equalto 75000/mm3
HB more than and equal to 9.0 gm/dl
5.Adequate hepatic function at screening as defined by:
Bilirubin less than and equal to 1.5 X ULN (upper limit of normal)
AST/ ALT less than and equal to 5 X ULN
6.Adequate renal function at screening as defined by S. creatinine less than and equal to 1.5 X ULN or creatinine clearance more than equal to 60ml/min.
7.Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or amenorrhoea for at least 12 consecutive months, must agree to use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner sexual partner) from screening, during the study and till the study completion (i.e. post study safety assessment after last PK sample collection in period II).
And Sexually active women must have a negative pregnancy test (at screening, before check-in on day 0) as well as must be non-lactating at the time of screening.
8.Willing and able to comply with housing, restrictions and other protocol requirements as indicated by signed written informed consent witnessed by a legally acceptable representative.
9.Patients should be otherwise healthy (except for the indication for which the antipsychotic treatment is given) as determined by physical examination, medical history and routine laboratory assessments. 
 
ExclusionCriteria 
Details  1.A history of allergic reactions / hypersensitivity to risperidone or other excipients of study drug.
2.Subject with history of hospitalisation for an exacerbation of schizophrenia within two months prior to screening and during the screening period.
3.Concurrent primary psychiatric (other than schizophrenia) or neurological diagnosis, including neurologic malignant syndrome, organic mental disorder, severe tardive dyskinesia, Parkinson’s disease, history or presence of epilepsy or risk for seizures or other conditions that potentially lower the seizure threshold, history of cerebrovascular disease.
4.Subject who is having :
Clinically significant cardiac disorders (e.g. myocarditis, cardiomyopathy, bradycardia) or QTc> 500 milliseconds or Uncontrolled hypertension, unstable angina, recent history of myocardial infraction.
Myeloproliferative disorders (drug-induced or idiopathic).
Significant orthostatic hypotension at screening or before checkin on day 0; orthostatic hypotension will be considered when there is drop in systolic blood pressure of 30 mm Hg or more or diastolic blood pressure of 20 mm Hg or more on standing from supine measurements.
Presence of uncontrolled metabolic disorders including diabetes mellitus(HbA1c morethan 8 %).
Significant hyperprolactinaemia or with possible prolactin-dependent tumours.
History/presence of venous thromboembolism.
5.Expected changes in concomitant medications during the period of study.
6.Positive urine drug scan test (for drugs) or alcohol breath test (for alcohol abuse) at screening or baseline.
7.Patients who are on active treatment with drugs that are known to interact with risperidone (such as Strong CYP2D6 inhibitors,CYP3A4 and/or P-gp inhibitors or inducers, drugs known to prolong the QT interval; detailed list is provided in Annexure III).
Note: If the patient was on any of these drugs, sufficient wash out period (of at least 5 half-lives) must have elapsed since the last dose of such drug before the first dose of investigational medicinal product for the current study.
8.A medical or surgical condition that might interfere with the absorption, metabolism, or excretion of risperidone.
9.Patients undergone major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery.
10.Patients with known positivity for human immunodeficiency virus (HIV), HBsAg or HCV.
11.Chronic Smokers who smokes greater than or equal to 10 cigarettes or equivalent per day.
12.History of difficulty with donating blood or difficulty in accessibility of veins.
13.Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study.
14.Participation in any other clinical study and 5 half lives of the previous IMP has not elapsed since receipt of the last dose of previous IMP receipt at screening.
15.An unusual or abnormal diet, for whatever reason planned e.g. religious fasting during the course of the study.
16.Any condition/ abnormal baseline findings that in the Investigators’ judgment might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study e.g. low expectation of compliance to dosing or expected changes in concomitant medication that may interfere in study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To demonstrate the bioequivalence at steady-state of Risperidone prolonged-release suspension for intramuscular injection 25 mg/vial of Pharmathen S.A., Greece in comparison with RISPERDAL CONSTA 25 mg powder and solvent for prolonged-release suspension for intramuscular injection Manufactured by: Janssen Pharmaceutica N.V., Beerse, Belgium in adult schizophrenic patients who are already receiving Risperidone prolonged-release suspension for intramuscular injection 25 mg/vial.   A total 47 blood samples will be collected. The pre dose blood sample will be collected within 5 min before dose1,2,3,4. After dose 4 administration in each period, the post-dose samples will be drawn at 4hr (d0),8hr(d0),24hrs(d1),36hr(d1),48hr(d2),72hr(d3),96hr(d4),120hr(d5),144hr(d6),156hr(d6),168hr(d7),180hr(d7),192hr(d8),204hr(d8),216hr(D9),240hr(d10),264 hr(d11),288hr (d12),312hr(d13),336hr(D14)following dose 4 drug administration in each period. 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor safety and tolerability profile of the study formulation.  NA 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/02/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Male and nonpregnant female patients with schizophrenia who are already receiving Risperidone 25 mg/vial prolonged-release suspension for injection via the intramuscular route will be eligible for screening and the study enrolment. Based on eligibility assessments, patient will receive his/her established maintenance dose of Risperidone 25 mg/vial prolonged-release suspension for injection via the intramuscular route every two weeks as per randomization schedule (either the test or reference product) in a crossover design at gluteal injection site for total of 4 doses in each period. The site of administration will be alternated between two buttocks in two subsequent doses in each period.

 
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