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CTRI Number  CTRI/2019/08/020536 [Registered on: 05/08/2019] Trial Registered Prospectively
Last Modified On: 08/07/2021
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   Bioequivalence study of Quetiapine Fumarate 300 mg tablets in adult schizophrenia patients, who was already receiving Quetiapine in a stable regimen 
Scientific Title of Study   An Open label, Multi-centre, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Multiple-dose, Steady-state, Cross-over, Bioequivalence study of Quetiapine Fumarate tablets 300 mg of Prinston Pharmaceutical Inc. comparing with that of SEROQUEL® (Quetiapine Fumarate) tablets 300 mg of AstraZeneca Pharmaceuticals LP, USA when administered twice daily in adult schizophrenia patients already receiving Quetiapine in a stable regimen. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
P-618/19 Version No.00 dated 10-May-2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr V V S Shiva Prasad 
Designation  Cheif Operating Officer  
Affiliation  QPS Bioserve India Private Limited 
Address  # 6-56/6/1A,OPP: IDPL Factory, Balanagar,Hyderabad.

Medchal
TELANGANA
500037
India 
Phone  91-40-43770873  
Fax    
Email  shiva@qps.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Bhaskara Rao K N S  
Designation  Sr.Manager-QA 
Affiliation  QPS Bioserve India Private Limited 
Address  # 6-56/6/1A,OPP: IDPL Factory, Balanagar,Hyderabad.

Medchal
TELANGANA
500037
India 
Phone  91-40-43770873  
Fax    
Email  bhaskar@qps.com  
 
Details of Contact Person
Public Query  
Name  Mr O Suresh  
Designation  Project Manager 
Affiliation  QPS Bioserve India Private Limited 
Address  # 6-56/6/1A,OPP: IDPL Factory, Balanagar,Hyderabad.

Medchal
TELANGANA
500037
India 
Phone  91-40-43770873  
Fax    
Email  suresh.oduru@qps.com  
 
Source of Monetary or Material Support  
Prinston Pharmaceutical Inc 2002 Eastpark Blvd Cranbury,NJ 08512 
 
Primary Sponsor  
Name  Prinston Pharmaceutical Inc 
Address  2002 Eastpark Blvd Cranbury, NJ 08512,USA 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr T S Sathyanarayana Rao  JSS Medical College Hospital  JSS Medical College Hospital MG Road, Mysore, Karnataka-570004
Mysore
KARNATAKA 		 9845282399

tssrao19@yahoo.com 
Dr Dalaya Nitin Veersingh  Life Point Multispeciality Hospital  Life Point Multispeciality Hospital 145/1, Mumbai – Bangalore Highway, Near Hotel Sayaji, Wakad, Pune , Maharashtra-411057
Pune
MAHARASHTRA 		 9552503201

drdalaya@nityanandrehab.com 
Dr Radhika Reddy V  Old Government General Hospital, (Associated By Govt. Siddhartha Medical College)  Old Government General Hospital, (Associated By Govt. Siddhartha Medical College)Hanumanpet, Two town, Vijayawada, Andhra Pradesh-520002
Krishna
ANDHRA PRADESH 		 91-866-2450391

rrvemireddy@yahoo.com 
Dr Vaishal N Vora  Ratandeep Multispeciality Hospital  Ratandeep Multispeciality Hospital, 5th Floor, Nakshatra Complex, Above HDFC Bank, Maninagar Cross Road, Maninagar, Ahmedabad, Gujarat-380008
Ahmadabad
GUJARAT 		 9825440891

vnvora@gmail.com 
Dr R Sathianathan  Sri Ramachandra Institute of Higher Education & Research  Sri Ramachandra Institute of Higher Education & Research (SRIHER),No.1, Ramachandra Nagar, , Porur, Chennai, Tamil Nadu-600116
Chennai
TAMIL NADU 		 9841019910

sathianathen6@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institutional Ethics Committee  Submittted/Under Review 
Institutional Ethics Committee, Sri Ramachandra Institute of Higher Education & Research (SRIHER)  Submittted/Under Review 
Institutional Ethics Committee-Siddhartha Medical College & Govt. General hospital (IEC-SMC & GGH)  Approved 
LPR 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 
Intervention  Quetiapine Fumarate Tablets 300 mg  Patients will receive a single dose of, Quetiapine Fumarate Tablets 300 mg, either Period-I (Day 1 to Day 5) or Period-II (Day 6 to Day 10) as per the randomization schedule.  
Comparator Agent  SEROQUEL® Quetiapine Fumarate Tablets 300 mg  Patients will receive a single dose of, Quetiapine Fumarate Tablets 300 mg, either Period-I (Day 1 to Day 5) or Period-II (Day 6 to Day 10) as per the randomization schedule.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Male or female aged 18-65 years (both inclusive) with BMI 18 to 35 kg/m2
2 Patients with clinically diagnosis of Schizophrenia (DSM-IV-TR) and who are in a stable regimen of Quetiapine 300 mg twice daily atleast one month prior to screening
3 Not having any significant diseases or abnormal findings except schizophrenia.
4 Acceptable Haematological parameters, Hepatic and Renal function at screening
5 Patient should have adequate ability to provide decision for informed consent along with legally acceptable representative.
6 Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal women 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 or sterile sexual partner for at least 2 weeks prior to the study and up to 30 days after the last dose of the study drug
7 In case of male patients: Either partner or patient must use an effective method of contraception for avoiding pregnancy for at least 2 weeks prior to the study drug administration, during the study and up to 30 days after the last dose

 
 
ExclusionCriteria 
Details  i.History of Hypersensitivity to Quetiapine or any of the excipients of study drug.
ii.Patient with dementia related psychosis.
iii.Patient with a history of Neuroleptic malignant Syndrome (NMS).
iv.Any psychiatric illness (Other than Schizophrenia) neurological disorders, including neurologic malignant syndrome, major depressive disorder, organic mental disorder, severe tardive dyskinesia, Parkinson’s disease, history or presence of epilepsy or risk for seizures, history of multiple syncopal episodes or stroke.
v.Patient who had undergone exacerbation of Schizophrenia and ECT (Electro convulsive therapy) within two months from the screening.
vi.History of suicidal tendencies or or immediate risk of harm to self or other (e.g. suicidal attempts) within the past 2 months prior to screening as judged by the investigator.
vii.Patient with history or presence of seizures or other conditions that potentially lower the seizure threshold, cognitive and motor impairment.
viii.Hospitalization for an exacerbation of schizophrenia with in two Months.
ix.Patient with significant clinical relevant endocrinal, cerebrovascular, pulmonary, haematological, immunological and cardiovascular disease (e.g., heart failure, history of myocardial infarction or ischemia, conduction abnormalities, cardiomyopathy, myocarditis), cerebrovascular disease, or conditions that predispose the patient to hypotension (e.g., dehydration, hypovolemia, and treatment with antihypertensive medications). Could lead to safety risk.
x.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, hypokalemia or hypomagnesemia, concomitant use of other drugs that prolong the QTc interval; and presence of congenital prolongation of the QT interval (QTc> 440 ms).
xi.Presence of uncontrolled metabolic disorders including uncontrolled diabetes mellitus (Fasting blood glucose levels greater than 160 mg/dl and HbA1c greater than or equal 8%), Serum total cholesterol greater than or equal 300 mg/dl and fasting serum triglyceride levels greater than or equal 300 mg/dl.
xii.Patient with clinically significant hyperprolactinemia or with possible prolactin dependent tumor.
xiii.Patient with known hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose¬galactose malabsorption.
xiv.Patient having Systolic Blood Pressure ≥ 140 mm Hg or Diastolic Blood Pressure ≥ 90 mm Hg.
xv.Use of any of the following medications within 14 days prior to enrolment but not limited to:
• Strong inhibitors of CYP3A4
• Strong inducers of CYP3A4
• Drugs associated with QT prolongation
• Antihypertensive and other drugs known to cause hypotension
xvi.Female patient with Positive Pregnancy test.
xvii.Patient with known positivity for human immunodeficiency virus (HIV), HBsAg or HCV.
xviii.Patient had major surgery within 2 months prior to study entry, or who have not recovered from prior major surgery.
xix.Patient with history of venous thromboembolism or conditions that predispose the risk of embolism.
xx.Medical or surgical condition that might interfere with the absorption, metabolism or excretion of Quetiapine.
xxi.Patient with chronic Smokers who smokes greater than or equal to 10 cigarettes or equivalent per day.
xxii.Patient with difficulty of donating blood or difficulty in accessibility of veins.
xxiii.Participation in a drug research study within past 3 months.
xxiv.A depot neuroleptic drugs within 3 months prior to administration of study medication.
xxv.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   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the bioequivalence of Quetiapine Fumarate tablets 300 mg of Prinston Pharmaceutical Inc. comparing with that of SEROQUEL® (Quetiapine fumarate) tablets 300 mg of AstraZeneca Pharmaceuticals LP, USA, when administered twice daily in adult schizophrenia patients already receiving Quetiapine in a stable regimen.  During the entire duration of the trial 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the bioequivalence of Quetiapine Fumarate tablets 300 mg of Prinston Pharmaceutical Inc. comparing with that of SEROQUEL® (Quetiapine fumarate) tablets 300 mg of AstraZeneca Pharmaceuticals LP, USA, when administered twice daily in adult schizophrenia patients already receiving Quetiapine in a stable regimen.  During the entire duration of the trial 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/08/2019 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The purpose of the study is to evaluate the bioequivalence of Quetiapine Fumarate tablets 300 mg,  Prinston Pharmaceutical Inc with SEROQUEL® in adult schizophrenia patients. 
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