| CTRI Number |
CTRI/2012/05/002632 [Registered on: 08/05/2012] Trial Registered Prospectively |
| Last Modified On: |
24/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A Bioequivalence study of two formulations of Quetiapine film coated tablets in adult
schizophrenic patients |
|
Scientific Title of Study
|
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 Hetero
Labs Limited, India) to the reference listed drug Seroquel® film coated tablets 300mg (Manufactured by AstraZeneca USA) under fasting conditions after multiple dose administration at steady state in adult
schizophrenic patients stabilized on Quetiapine 600 mg per day. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 517-11, Verson No. 01 dated 15 March 2012 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajesh CN |
| Designation |
Project Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Near Gujarat High court,
S.G. Highway, Gota,
Ahmedabad-380061,
Gujarat, India.
Ahmadabad
GUJARAT
380061
India |
| Phone |
079-40202051 |
| Fax |
079-40202022 |
| Email |
rajeshcn@lambda-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen Shetty |
| Designation |
Assistant Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Near Gujarat High court,
S.G. Highway, Gota,
Ahmedabad-380061,
Gujarat, India.
Ahmadabad
GUJARAT
380061
India |
| Phone |
079-40202098 |
| Fax |
079-40202022 |
| Email |
praveenshetty@lambda-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen Shetty |
| Designation |
Assistant Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Near Gujarat High court,
S.G. Highway, Gota,
Ahmedabad-380061,
Gujarat, India.
Ahmadabad
GUJARAT
380061
India |
| Phone |
079-40202098 |
| Fax |
079-40202022 |
| Email |
praveenshetty@lambda-cro.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Hetero Labs Limited |
| Address |
7-2-A2, Hetero Corporate, Industrial Estates, Sanathnagar, Hyderabad – 500
018. Andhra Pradesh, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrRajendra Anand |
Anand Hospital |
Clinical Research Department,
GHA-4, besides Dena bank, sector 16, Ghandhinagar-382016, Gujarat, India.
Gandhinagar
GUJARAT |
91-9824017400
drrajendraanand@yahoo.com |
| DrTimir Shah |
Divyam Hospital |
Clinical Research Department,
41-44, Maher Park-A Nr. Athwa gate, Ring Road, Surat-395001, Gujarat, India.
Surat
GUJARAT |
91-9825137443
drtcshah@yahoo.co.in |
| DrBakul Buch |
Hatkesh Healthcare Foundation |
Clinical Research Department, Opp.Bhutnath temple, College road, Junagadh-362001, Gujarat, India.
Junagadh
GUJARAT |
91-9825220330
bakulbuch@gmail.com |
| Dr Vaishal Vora |
Sneh Clinic |
Clinical Research Department,
301-2-3, Nakshatra complex, Above HDFC Bank, Maninagar cross road, Maninagar, Ahmedabad-380008, Gujarat, India.
Ahmadabad
GUJARAT |
91-9825440891
vnvora@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Independent Ethical Review committee/Surat/Dr.Timir Shah |
Approved |
| Independent Ethics Committee/Ahmedabad/Dr Vaishal Vora |
Approved |
| Shashvat Ethics committee/Rajkot/Dr.Bakul Buch |
Approved |
| Spandan Independent Ethics Committee/Ahmedabad/Dr.Rajendra Anand |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F209||Schizophrenia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Quetiapine film coated tablets 300 mg (as quetiapine fumarate) |
Twice daily per day
Patient will receive test drug for 5 consecutive days followed by reference product for another 5 consecutive days OR vice-versa.
|
| Comparator Agent |
Seroquel® film coated tablets 300 mg |
Patient will receive test drug for 5 consecutive days followed by reference product for another 5 consecutive days OR vice-versa.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient has a documented clinical diagnosis of schizophrenia (DSM IV-TR) and on a stable dose of Quetiapine 600 mg per day for at least 10 days prior to screening.
2. Having a Body Mass Index (BMI) between 18 and 30 (both inclusive), calculated as weight in kg / height in m2.
3. The investigator must ensure that the respective hepatic, renal, haematopoietic, cardiac and respiratory functions are appropriate to include the patient in the study.
4. Able to comply with study procedures in the opinion of the investigator.
5. 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. Cessation of birth control after this point should be discussed with a responsible physician.
6. 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. Cessation of birth control after this point should be discussed with a responsible physician. |
|
| 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 mmHg or a diastolic blood pressure decrease of at least 10 mmHg within three minutes of standing up).
4. History of syncope or orthostatic hypotension.
5. 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 prior to receiving study medication or inability to abstain from alcohol during the study.
6. Smokers who has inability to abstain from smoking during the study.
7. Known case of HIV infection.
8. 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.
9. Hospitalisation for an exacerbation of schizophrenia within two months prior to screening and during the screening period.
10. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
11. History of agranulocytosis.
12. 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 film coated tablets 300 mg) with respect to the reference formulation (Seroquel® film coated 300 mg
tablets) in adult Schizophrenic patients (stabilized on Quetiapine 600 mg per day) under fasting conditions and to
assess the bioequivalence. |
- |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety of the patients who are exposed to the investigational medicinal product. |
_ |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/05/2012 |
| 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="6"
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
|
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 and to assess the bioequivalence. 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. |