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CTRI Number  CTRI/2011/08/001949 [Registered on: 12/08/2011] Trial Registered Prospectively
Last Modified On: 21/12/2011
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   A clinical trial to study Bioequivalence of two formulations of Quetiapine fumarate 300mg in Adult Patients suffering from schizophrenia.  
Scientific Title of Study   A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO-TREATMENT, TWOSEQUENCE, CROSS-OVER, STEADY-STATE BIOEQUIVALENCE STUDY OF QUETIAPINE FUMARATE TABLETS 300 MG MANUFACTURED BY AMNEAL (TEST) WITH SEROQUEL® (QUETIAPINE FUMARATE) 300 MG TABLETS MANUFACTURED BY ASTRAZENECA (REFERENCE) IN ADULT SCHIZOPHRENIC PATIENTS ALREADY RECEIVING/ STABILIZED WITH QUETIAPINE 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
ARL/CT/11/035  Protocol Number 
CR001-10  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Agam Shah 
Designation  Lead Research Coordinator - Clinical Trials 
Affiliation  Accutest Research Laboratories Pvt. Ltd. 
Address  Opp. The Grand Bhagwati Hotel, Sarkhej Gandhinagar Highway
Bodakdev, Ahmedabad
Ahmadabad
GUJARAT
380054
India 
Phone  917940029312  
Fax  917940029317  
Email  agam.shah@accutestindia.com  
 
Details of Contact Person
Public Query  
Name  Mr Prasann Bavania 
Designation  Senior Research Associate 
Affiliation  Accutest Research Laboratories Pvt. Ltd. 
Address  Opp. The Grand Bhagwati Hotel, Sarkhej Gandhinagar Highway
Bodakdev, Ahmedabad
Ahmadabad
GUJARAT
380054
India 
Phone  917940029312  
Fax  917940029317  
Email  prasann.bavania@accutestindia.com  
 
Source of Monetary or Material Support  
Amneal Pharmaceuticals LLC, USA 
 
Primary Sponsor  
Name  Amneal Pharmaceuticals LLC 
Address  85 Adams Avenue Hauppauge, NY 11788 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 = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajendra Anand  Anand Hospital  Anand Hospital, Gh-4, Sector-16, B/h Dena Bank, Gandhinagar (Gujarat - India)
Gandhinagar
GUJARAT 		 079-23238853

drrajendraanand@yahoo.com 
Dr Timir Shah  Divyam Hospital  Divyam Mental Health Care Centre, 32, 37, 41, 42, 43, 46 Maher Park – A wing, Nr. Mahavir Cardiac Hospital, Athwagate, Ring Road, Surat – 395 001
Surat
GUJARAT 		 0261-2470870

drtcshah@yahoo.co.in 
Dr Nehalkumar Shah  Vraj Hospital  Vraj Hospital, 2nd Floor, 24 Carat, Nr. Pukhraj Hospital, Ramnagar Chowk, Sabarmati, Ahmedabad – 380005
Ahmadabad
GUJARAT 		 09925049569

drnehalshah@indiatimes.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
IBIOME-IEC, Ahmedabad for Anand Hospital  Approved 
IBIOME-IEC, Ahmedabad for Divyam Hospital  Approved 
Independent Ethics Committee-Aditya, Ahmedabad for Vraj Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Adult Schizophrenic Patients Already Receiving or Stabilized with Qetiapine,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Quetiapine Fumarate 300 mg IR tablets manufactured by Amneal Pharmaceuticals  Twice daily for 5 days of test period 
Comparator Agent  Seroquel® 300 mg tablets manufactured by AstraZeneca  Twice daily for 5 days of reference period 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Adult schizophrenic patients with body mass index (BMI) between 18 and
35kg/m2, inclusive, and aged between 18 and 60 years, inclusive. on stable
regimen with Quetiapine 300 mg IR preparation Q12h
2. Confirmed by a psychiatrist according to the Diagnostic and Statistical Manual IV
(DSM IV) criteria
3. Able to comprehend the full nature and purpose of the study, including possible
risks and adverse events; ability to co-operate with the investigator and to
comply with the requirements of the entire study
4. Signed written informed consent prior to inclusion in the study witnessed by a
legally acceptable representative or guardian
5. Should be otherwise healthy as determined by physical examination, medical
history, and no significant abnormality in any of the laboratory parameters
including ECG and Chest X-ray
6. Body weight ≥ 45kgs
7. Adequate hemoglobin i.e. ≥10gm/dL
8. Adequate renal function at screening as defined by Creatinine 1.5 X ULN for the
clinical laboratory
9. Female patients of childbearing potential must be willing to use a reliable method
of birth control, i.e. barrier method, intrauterine device, etc. during the study. 
 
ExclusionCriteria 
Details  1. Known to have significant orthostatic hypotension
2. Known to have tachycardia or tachyarrhythmia
3. Bouts of uncontrolled seizures
4. Concurrent primary psychiatric or neurological diagnosis, including organic mental
disorder, severe tardive dyskinesia, idiopathic Parkinson¡¯s disease or Alzheimer¡¯s
dementia
5. Used any investigational drug within 3 months before Screening
6. On anticoagulants
7. Blood donations/ losses within 60 days of Screening
8. history of arrhythmias, hypokalemia, hypomagnesemia, or congenital QT
prolongation History of multiple syncopal episodes
9. History of alcoholism within 3 months prior to Screening
10. History of drug abuse or dependence within 3 months prior to Screening
11. A value at Screening is greater than 1.5 times the upper limit of reference range
for AST, ALT, direct bilirubin, total triglycerides, or total cholesterol
12. Contraindications or hypersensitivity to the use of Quetiapine or related group of
drugs
13. Class III heart failure with evidence of recent progression, or Class IV heart failure per NYHA functional classification system
14. Uncontrolled and untreated hypertension
15. Myocardial infarction or acute coronary syndrome within 6 months prior to
Screening
16. Significant pre-existing gastrointestinal co-morbidities that would preclude
compliance with oral medication.
17. History of suicidal tendencies within the past 3 months prior to Screening or immediate risk of harm to self or other at the time of
Screening, as judged by the investigator
18. Uncontrolled and un-treated diabetes mellitus
19. An unusual or abnormal diet, for whatever reason e.g. religious fasting
20. Smoking¡Ý 9 cigarettes/beedies per day
21. With bleeding disorders
22. On treatment with alpha adrenergic receptor blocking agents
23. Pregnant females as determined by positive serum or urine hCG test at Screening or prior to the first dose of study medication (Day 1)
24. Lactating female
25. On class 1A antiarrhythmics, class III antiarrhythmics, antipsychotics, antibiotics, other drugs associated with QT prolongation
26. On drugs which are enzyme inducer or inhibitors of CYP450 3A4, 5, and 7. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. AUC0-tau: Area under the plasma concentration to time curve over the steady state
dosing interval.
2. Cmax-ss: Maximum concentration over the steady state dosing interval.
3. Cmin-ss: Minimum concentration over the steady state dosing interval. 		 Dosing interval on day 5 and day 10. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Css-avg: Average concentration over the steady state dosing interval.
2. Percentage fluctuation: [Cmax-ss – Cmin-ss / Css-avg] x 100
3. Tmax: Time of maximum measured plasma concentration over the steady state dosing interval.
4. Safety and tolerability as assessed by reported adverse events 		 1, 2 and 3 - Dosing interval on day 5 and day 10.
4 - throughout the study period 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/08/2011 
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="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This is a Multicentrer, Open Label, Randomized, Two-Treatment, Two-Sequence, Crossover, Steady state Bioequivalence Study of Two formulations of Quetiapine fumarate tablet 300 mg in Adult Patients suffering from schizophrenia.

It is expected that sponsors test formulation will show pharmacokinetics similar to that of the reference listed drug and will prove bioequivalent to the reference drug.

The trial will be conducted in Indian patients only and within India only. Anticipated date for first patient enrolment in the study is end of August, 2011.
 
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