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1 Clinical Trial Details (PDF Generation Date :- Fri, 12 Oct :11:01 GMT) CTRI Number Last Modified On 31/08/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/09/ [Registered on: 04/09/2012] - Trial Registered Prospectively No BA/BE Randomized, Crossover Trial 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 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 Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) , Version 01, Dated 14 June 2012 Protocol Number Designation Affiliation Details of Principal Investigator Mr Priyajeet Parekh Project Manager Phone Fax Designation Affiliation Lambda Therapeutic Research Ltd. Near Gujarat High court, S. G. Highway, Gota, Ahmedabad priyajeetparekh@lambda-cro.com Details Contact Person (Scientific Query) Dr Praveen Shetty Manager Phone Fax Designation Affiliation Lambda Therapeutic Research Ltd. Near Gujarat High court, S. G. Highway, Gota, Ahmedabad praveenshetty@lambda-cro.com Details Contact Person (Public Query) Dr Ankit Ranpura Asst. Manager Lambda Therapeutic Research Ltd. Near Gujarat High court, S. G. Highway, Gota, Ahmedabad page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Phone Fax > Pharmathen S.A. Type of Sponsor Source of Monetary or Material Support Primary Sponsor Details Pharmathen SA 6 Dervenakion str., Pallini, Athens-Greece Pharmaceutical industry-global Lambda Therapeutic Research Ltd Lambda Therapeutic Research Ltd., Plot No. 38, Near Silver Oak Club, S. G. Highway, Gota Ahmedabad Gujarat,. List of Countries of Principal Investigator of Site Site Phone/Fax/ Dr Rajendra Anand Anand Hospital Department of Psychiatry, Anand Hospital,GH-4, besides Dena bank, sector 16, Ghandhinagar Gandhinagar Dr Timir Shah Divyam Hospital Department of Psychiatry, Divyam Hospital, 41-44, Maher Park-A Nr. Athwa gate, Ring Road, Surat Surat Dr Bakul Buch Hatkesh Healthcare Foundation Department of Psychiatry, Hatkesh Healthcare Foundation, Opp. Bhutnath temple, College road, Junagadh Junagadh Dr Vaishal Vora Sneh Clinic Department of Psychiatry, Sneh Clinic, , Nakshatra complex, Above HDFC Bank, Maninagar cross road, Maninagar, Ahmedabad drrajendraanand@yaho o.com drtcshah@yahoo.co.in bakulbuch@gmail.com vnvora@gmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? PI Dr. Timir shah Approved 02/07/2012 Yes page 2 / 6

3 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Research Independent Ethics Committee, Surat PI- Dr. Bakul Buch-Hatkesh Health Care Foundation Ethics Committee, Junagadh PI-Dr. Rajendra Anand Spandan Independent Ethics Committee, Ahmedabad PI-Dr. Vora-Independent Ethics Committee, Ahmedabad Status Approved 03/07/2012 No Approved 21/07/2012 Yes Approved 19/07/2012 Yes Date Approved/Obtained 29/08/2012 Health Type Patients Condition Adult schizophrenic patients (stabilized on Quetiapine 400 mg per day) Type Details Intervention Comparator Agent Age From Age To Gender Details Quetiapine extended release tablets 400 mg Seroquel Prolong 400 mg tablets Year(s) Year(s) Both Inclusion Criteria 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 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 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 page 3 / 6

4 Exclusion Criteria Details 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) Exclusion Criteria 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 page 4 / 6

5 Method of Generating Random Sequence Method of Concealment Blinding/Masking Other Other Open Label 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 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 Target Sample Size Phase of Trial Date of First Enrollment () Date of First Enrollment (Global) To monitor the safety of the patients who are exposed to the investigational medicinal product Total Sample Size=51 Sample Size from =51 N/A 07/09/2012 No Date Specified Safety assessment will be done till the end of study page 5 / 6

6 Powered by TCPDF ( PDF of Trial Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Years=0 Months=4 Days=0 Not Applicable Completed Not Applicable 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. page 6 / 6