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CTRI Number  CTRI/2012/09/002956 [Registered on: 04/09/2012] Trial Registered Prospectively
Last Modified On: 12/11/2018
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   Bioequivalence study comparing Quetiapine extended release tablets 400 mg (Pharmathen S.A.) to the reference listed drug Seroquel® tablets under fasting conditions after multiple dose administration at steady state in adult schizophrenic patients stabilized on Quetiapine 400 mg per day 
Scientific Title of Study   A multicentre, balanced, randomized, open label, three-period, two-treatment, three sequences, reference replicate, crossover, bioequivalence study comparing Quetiapine extended release tablets 400 mg (Manufactured by: Pharmathen S.A., Greece) to the reference listed drug Seroquel® Prolong 400 mg tablets (Manufactured by: AstraZeneca UK Limited., United Kingdom) under fasting conditions after multiple dose administration at steady state in adult schizophrenic patients stabilized on Quetiapine 400 mg per day 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
190-12, Version 01, Dated 14 June 2012  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Priyajeet Parekh 
Designation  Project Manager 
Affiliation  Lambda Therapeutic Research Ltd. 
Address  Near Gujarat High court, S. G. Highway, Gota, Ahmedabad

Ahmadabad
GUJARAT
380061
India 
Phone  09879567660  
Fax  07940202021  
Email  priyajeetparekh@lambda-cro.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Praveen Shetty 
Designation  Manager  
Affiliation  Lambda Therapeutic Research Ltd. 
Address  Near Gujarat High court, S. G. Highway, Gota, Ahmedabad

Ahmadabad
GUJARAT
380061
India 
Phone  09377247252  
Fax  07940202021  
Email  praveenshetty@lambda-cro.com  
 
Details of Contact Person
Public Query  
Name  Dr Ankit Ranpura 
Designation  Asst. Manager 
Affiliation  Lambda Therapeutic Research Ltd. 
Address  Near Gujarat High court, S. G. Highway, Gota, Ahmedabad

Ahmadabad
GUJARAT
380061
India 
Phone  08460062870  
Fax  07940204021  
Email  ankitranpura@lambda-cro.com  
 
Source of Monetary or Material Support  
Pharmathen S.A. 
 
Primary Sponsor  
Name  Pharmathen SA 
Address  6 Dervenakion str., 153 51 Pallini, Athens-Greece 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Lambda Therapeutic Research Ltd  Lambda Therapeutic Research Ltd., Plot No. 38, Near Silver Oak Club, S. G. Highway, Gota Ahmedabad- 380061 Gujarat, India.  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajendra Anand  Anand Hospital  Department of Psychiatry, Anand Hospital,GH-4, besides Dena bank, sector 16, Ghandhinagar-382016
Gandhinagar
GUJARAT 		 09824017400

drrajendraanand@yahoo.com 
Dr Timir Shah  Divyam Hospital  Department of Psychiatry, Divyam Hospital, 41-44, Maher Park-A Nr. Athwa gate, Ring Road, Surat-395001
Surat
GUJARAT 		 9825137443

drtcshah@yahoo.co.in 
Dr Bakul Buch   Hatkesh Healthcare Foundation  Department of Psychiatry, Hatkesh Healthcare Foundation, Opp. Bhutnath temple, College road, Junagadh-362001
Junagadh
GUJARAT 		 9825220330

bakulbuch@gmail.com 
Dr Vaishal Vora  Sneh Clinic  Department of Psychiatry, Sneh Clinic, 301-2-3, Nakshatra complex, Above HDFC Bank, Maninagar cross road, Maninagar, Ahmedabad-380008
Ahmadabad
GUJARAT 		 09825440891

vnvora@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
PI Dr. Timir shah Research Independent Ethics Committee, Surat  Approved 
PI- Dr. Bakul Buch-Hatkesh Health Care Foundation Ethics Committee, Junagadh  Approved 
PI-Dr. Rajendra Anand Spandan Independent Ethics Committee, Ahmedabad  Approved 
PI-Dr. Vora-Independent Ethics Committee, Ahmedabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Adult schizophrenic patients (stabilized on Quetiapine 400 mg per day), (1) ICD-10 Condition: F208||Other schizophrenia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Quetiapine extended release tablets 400 mg  One Quetiapine Extended Release tablet 400 mg will be administered orally, while in sitting posture, to each patient with 240 ml of drinking water, at ambient temperature 
Comparator Agent  Seroquel® Prolong 400 mg tablets  One Seroquel® Prolong 400 mg tablet will be administered orally, while in sitting posture, to each patient with 240 ml of drinking water, at ambient temperature 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Written informed consent for participation in the study by the patient and Patient’s Legally Acceptable Representative (LAR)
2.Patient has a documented clinical diagnosis of schizophrenia (DSM IV-TR)
3.Patient should be on a stable dose of Quetiapine 400 mg per day for at least 14 days prior to screening
4.Having a Body Mass Index (BMI) between 18 and 30 (both inclusive), calculated as weight in kg/height in m2
5.Able to comply with study procedures in the opinion of the investigator
6.In case of female patient the serum pregnancy test at screening visit and urine pregnancy test at day 1 (before dosing) must be negative
7.Sexually active women, unless surgically sterile (at least 6 months prior to Study drug administration) or postmenopausal for at least 12 consecutive months, must 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 [at least 6 months prior to Study drug administration] sexual partner) for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug
8.In case of Male patients: Either partner or patient must use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug
(It is investigator’s responsibility to ensure that above points regarding an effective method of avoiding pregnancy are discussed with patient/LAR in detail and patient agreed for this and it is documented in source document. The investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol) 
 
ExclusionCriteria 
Details  1. Known hypersensitivity or idiosyncratic reaction to Quetiapine and its excipients
2. Current or relevant history of serious, severe or unstable psychiatric illness except schizophrenia
3. Presence of Postural Hypotension (Defined as systolic blood pressure decrease of at least 20 mm Hg or a diastolic blood pressure decrease of at least 10 mm Hg within three minutes of standing up)
4. History of syncope or orthostatic hypotension
5. Ingestion of any medication other than listed below at any time in 10 days before the first study drug administration. In any such case Patient selection will be at the discretion of the Principal Investigator / Medical Expert. Following is the list of permissible medications, provided, the patients are on a stable regimen at least 14 days prior to and throughout the study: Alprazolam, Fluoxetin, Imipramine, Haloperidol and Risperidone
6. A recent history of alcoholism (less than 2 years) or daily consumption of moderate (180 ml / day) alcohol use, or consumption of alcohol or alcoholic products within 48 hour of receiving study medication or inability to abstain from alcohol during the study
7. Smokers who has inability to abstain from smoking during the study
8. Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of study medication or during the study
9. A positive hepatitis screen including HBsAg, HCV and HAV IgM antibodies
10. Known case of HIV infection
11. Supine blood pressure less than 110/70 mmHg or pulse rate less than 60 or more than 100 beats per minute at screening
12. Any condition/ Abnormal baseline findings that in the investigator’s judgement might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study
13. The receipt of an investigational product or participation in a drug research study within a period of 30 days prior to the first dose of study medication
Note: Elimination half-life of the study drug should be taken into consideration for inclusion of the Patient in the study.
14. Psychosis judged to be the direct physiological effect of an abused medication or substance
15. Patients with a known intolerance or lack of response to previous treatment with Quetiapine
16. Positive testing for the drugs of abuse (amphetamines, barbiturates ,benzodiazepines, cocaine, morphine , marijuana) done by urine drug scan at day 0 (except for Alprazolam which is a permissible medication)
17. History of Organic Brain Disorder
18. Hospitalisation for an exacerbation of schizophrenia within two months prior to screening and during the screening period
19. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
20. Patients with the following cardiac conditions are excluded:
• Recent myocardial infarction (12 months)
• QTc prolongation (screening electrocardiogram with QTc 450 msec for men,QTc 470 msec for women)
• History of QTc prolongation or using concomitant medications which prolong QTc interval
• Sustained cardiac arrhythmia or history of sustained cardiac arrhythmia
• Uncompensated congestive heart failure
• Complete left bundle branch block
• First-degree heart block with PR interval 0.22 seconds
21. Presence of cataract on Opthalmoscopic examination (slit lamp exam)
22. History of Agranulocytosis
23. Patients having Hypertension or on any antihypertensive medication.
24. Patients with Diabetes mellitus or fasting blood glucose ≥ 126 mg/dl at screening visit.
25. Patients with abnormal thyroid function test at screening visit which as judged by Investigator could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial.
26. Patient with hyperprolactinemia at screening visit which as judged by investigator could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial.
27. Dementia related psychosis
28. Pregnant or lactating females 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the bioavailability and characterise the pharmacokinetic profile of the Sponsor’s formulation (Quetiapine Extended Release tablets 400 mg) with respect to the reference formulation (Seroquel® Prolong 400 mg tablets) in adult Schizophrenic patients (stabilized on Quetiapine 400 mg per day) under fasting conditions and to assess the bioequivalence  At the end of study 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the safety of the patients who are exposed to the investigational medicinal product  Safety assessment will be done till the end of study 
 
Target Sample Size   Total Sample Size="51"
Sample Size from India="51" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/09/2012 
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="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The Sponsor has developed the modified release test formulation of Quteiapine. Quetiapine is a psychotropic agent belonging to the chemical class the dibenzothiazepine derivatives. The mechanism of action of quetiapine, as with other drugs having efficacy in the treatment of schizophrenia, is unknown.

 

This study is being conducted to compare the bioavailability and characterise the pharmacokinetic profile of the Sponsor’s formulation (Quetiapine Extended Release tablets 400 mg) with respect to the reference formulation (Seroquel® Prolong 400 mg tablets) in Schizophrenic patients stabilized on Quetiapine 400 mg per day under fasting conditions and to assess the bioequivalence.

 

Healthy subjects experienced serious adverse effects after administration of antipsychotics such as hypotension, tachycardia etc. Hence, regulatory authorities are recommending that studies should be conducted on Schizophrenic patients.

The study is being conducted on schizophrenic patients who are on a stable dose of Quetiapine, and the patients cannot be deprived of the Quetiapine treatment during the washout period of the study. Hence, the study has been planned to be a continuous administration of the test and the reference formulation without any intervening washout period.

 

Since the formulation being studied is a modified release formulation, a multiple dose, steady state study is being conducted as per the applicable regulatory guidance. The multidose pharmacokinetics of Quetiapine is dose proportional within the proposed clinical dose range and Quetiapine accumulation is predictable upon multidosing.

 
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