| CTRI Number |
CTRI/2010/091/000181 [Registered on: 01/04/2010] |
| Last Modified On: |
13/11/2018 |
| Post Graduate Thesis |
|
| Type of Trial |
BA/BE |
Type of Study
Modification(s)
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|
| Study Design |
Randomized, Crossover Trial |
Public Title of Study
Modification(s)
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A Bioequivalence study to compare the Bioequivalence of two formulation of quetiapine in schizophrenic patients. |
Scientific Title of Study
Modification(s)
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An open label, balanced, randomized, two treatment, two-period, two-sequence, crossover, multicentric experimental bioequivalence study comparing Quetiapine film coated tablets 300 mg (Manufactured by Dr. Reddys Laboratories Ltd., India) to the reference listed drug Seroquel® film coated tablets 300 mg (Manufactured by AstraZeneca Pharmaceuticals LP, USA) under fasting conditions after multiple dose administration at steady state in adult schizophrenic patients stabilized on Quetiapine 600 mg per day. |
| Trial Acronym |
NA |
Secondary IDs if Any
Modification(s)
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| Secondary ID |
Identifier |
| 353-09 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
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| Name |
Dr Ashoka Kumar Singh |
| Designation |
|
| Affiliation |
|
| Address |
Lambda Therapeutic Research Limited Near Gujarat High Court
Ahmadabad
GUJARAT
380061
India |
| Phone |
09811126123 |
| Fax |
079-40202022 |
| Email |
ashokakumar@lambda-cro.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Praveen Shetty |
| Designation |
|
| Affiliation |
NIL |
| Address |
Lambda Therapeutic Research Limited,Near Gujarat High Court
Ahmadabad
GUJARAT
380061
India |
| Phone |
079-40202098 |
| Fax |
079-40202022 |
| Email |
praveenshetty@lambda-cro.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Praveen Shetty |
| Designation |
|
| Affiliation |
|
| Address |
Lambda Therapeutic Research Limited,Near Gujarat High Court
Ahmadabad
GUJARAT
380061
India |
| Phone |
079-40202098 |
| Fax |
079-40202022 |
| Email |
praveenshetty@lambda-cro.com |
|
Source of Monetary or Material Support
Modification(s)
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| Dr. Reddys Laboratories Ltd., India |
|
Primary Sponsor
Modification(s)
|
| Name |
Dr Reddys Laboratories Ltd India |
| Address |
Bachupally,Quthubullapur Mandal, Survey No:42,45 and 46, RR Dist-500072 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
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|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
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| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhay Paliwal |
Anand Hospital and Research Pvt. Ltd. |
7,Sandhu nagar, Bhanwar Kua Road,India-452 001
Indore
MADHYA PRADESH |
9826044402
07312496034
abhaypaliwal2@yahoo.com |
| Dr M S Reddy |
Asha Hospital |
Consultant Psychiatrist, # 298, Road No. 14, Banjara Hills,500 034.
Hyderabad
ANDHRA PRADESH |
09490116098
04023542574
drmsreddy@gamil.com |
| Dr R Sathianthan |
Department of Psychiatry |
Ward # 120, Department of Psychiatry,Madras Medical College & Government General Hospital,600003,
Chennai
TAMIL NADU |
9841019910
04425388989
sathianathen6@yahoo.com |
| Dr Sachin Patkar |
Masina Hospital |
Sant Savta Marg, Behind Gloria Church, Byculla, Mumbai - 400027
Mumbai
MAHARASHTRA |
02224091368
drsachinpatkar@sify.com |
| Dr B S V Prasad |
Sujata Birla Hospital |
Opp. Bytco college, Nashik Road-422101,
Nashik
MAHARASHTRA |
9822039737
bsvprasad2@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| CLINICAL ETHICS FORUM |
Approved |
| Ehics Committee Asha Hospital |
Approved |
| Madras Medical College and Government General Hospital, Chennai 600 003 |
Approved |
| Naitik; An Independent Ethics Committee |
Approved |
| North Maharastra Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
Modification(s)
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F209||Schizophrenia, unspecified, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Quetiapine film coated tablets 300 mg (as quetiapine fumarate) |
Patients will be administered either Test or Reference product twice daily for the first five days followed by crossover for the next five days as per randomization schedule no washout period between the two treatments. |
| Comparator Agent |
Seroquel® film coated tablets 300 mg |
Patients will be administered either Test or Reference product twice daily for the first five days followed by crossover for the next five days as per randomization schedule no washout period between the two treatments. |
|
Inclusion Criteria
Modification(s)
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| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Written informed consent for participation in the study by the patient and Patient?s Legally Acceptable Representative (LAR). If the patient or his/her legally acceptable representative is unable to read/write ? an impartial witness should be present during the entire informed consent process who must append his/her signatures to the consent form.
2.Patient has a documented clinical diagnosis of stable schizophrenia (DSM IV-TR) controlled by a stable 300 mg Quetiapine regimen given at 12-hour intervals from at least 2 weeks prior to the first dosing, as confirmed by Principal Investigator
3. Having a Body Mass Index (BMI) between 18 and 35 (inclusive), calculated as weight in kg / height in m2.
4. Not having any significant diseases or clinically significant abnormal findings except schizophrenia during screening, medical history, physical examination, laboratory evaluations, 12-lead ECG recordings and Chest X ray (Postero-anterior view).
5.The investigator must ensure that the respective hepatic, renal, haematopoietic, cardiac and respiratory functions are appropriate to include the patient in the study.
6.Able to comply with study procedures in the opinion of the investigator
|
|
| ExclusionCriteria |
| Details |
1. Known hypersensitivity/allergy or idiosyncratic reaction to Quetiapine or its excipients.
2. Clinically significant illnesses (including hypotensive episodes and systemic infection) or surgery within 4 weeks prior to the first dosing.
3. Current or relevant history of serious, severe or unstable psychiatric illness (Meeting the criteria for any other (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Axis I) except schizophrenia.
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. Following is the list of permissible medications, provided, the patients are on a stable regimen at least 10 days prior to and throughout the study.
Alprazolam, Fluoxetin, Imipramine, Haloperidol, Resperidone. (Refer Appendix-I for list of nonpermissible medication)
6. A history of alcohol or drug dependence by DSM-IV criteria within 6 months prior to screening.
7. Smokers who smoke 10 or more than 10 cigarette/day or 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.
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|
Method of Generating Random Sequence
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Other |
Method of Concealment
Modification(s)
|
Other |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To compare the bioavailability and characterise the pharmacokinetic profile of the Sponsor?s formulation (Quetiapine film coated tablets 300 mg) with respect to the reference formulation (Seroquel® film coated tablets 300 mg) in adult Schizophrenic patients (stabilized on Quetiapine 600 mg per day) under fasting conditions |
NIL |
|
Secondary Outcome
Modification(s)
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| Outcome |
TimePoints |
| To monitor the safety of the patients who are exposed to the investigational medicinal product. |
NIL |
|
Target Sample Size
Modification(s)
|
Total Sample Size="54"
Sample Size from India="54"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
27/04/2010 |
| 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
Modification(s)
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not applicable |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
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The Sponsor has developed the test formulation. This study is being conducted to compare the bioavailability and characterise the pharmacokinetic profile of the Sponsor's formulation (Quetiapine film coated tablets 300 mg) with respect to the reference formulation (Seroquel® film coated 300 mg tablets) in Schizophrenic patients under fasting conditions stabilized on Quetiapine 600 mg per day.
As a high number of healthy subjects experienced serious adverse effects after administration of antipsychotics such as hypotension, tachycardia etc., regulatory authorities are recommending that studies should be conducted on Schizophrenic patients.
In accordance with the FDA guidance for the demonstration of bioequivalence for Quetiapine fumarate (Finalised May 2008)4, bioequivalence of a generic version of Quetiapine tablets to the reference listed drug (RLD) Seroquel should be established using 3 in vivo studies: two single dose studies in healthy subjects with Quetiapine 25 mg administered under both fasting and fed conditions, and a steady-state study with Quetiapine 300 mg administered in schizophrenic patients already receiving Quetiapine in a stable regimen. The design proposed in this protocol complies with FDA recommendation for the latter study.
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
This study will enroll 54 adult Schizophrenic patients.
The anticipated date of enrollment would be on 07 April 2010.
Total Blood Loss :
Not exceeding 197 + 10 mL for each patient.
|