| CTRI Number |
CTRI/2010/091/000001 [Registered on: 19/01/2010] |
| Last Modified On: |
15/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
Type of Study
Modification(s)
|
|
| Study Design |
Randomized, Crossover Trial |
Public Title of Study
Modification(s)
|
A study to evaluate the bioequivalence of Quetiapine with Seroquel in adult schizophrenic patients. |
Scientific Title of Study
Modification(s)
|
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 Intas Pharmaceuticals Ltd., 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 |
NA |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 181-09, Version 00, 4 May 2010 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Rajesh CN |
| Designation |
Assistant General Manager |
| Affiliation |
Lambda Therapeutic Research Ltd. |
| Address |
Plot No. 38, Near Silver Oak Club,S.G. Highway, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
079-40202051 |
| Fax |
079-40202022 |
| Email |
rajeshcn@lambda-cro.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Praveen Shetty |
| Designation |
Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Plot No. 38, Near Silver Oak Club,S.G. Highway, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
079-40202098 |
| Fax |
|
| Email |
praveenshetty@lambda-cro.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Ankit Ranpura |
| Designation |
Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Plot No. 38, Near Silver Oak Club, S.G. Highway, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
917940202074 |
| Fax |
917940202022 |
| Email |
ankitranpura@lambda-cro.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Intas Pharmaceuticals Ltd |
|
Primary Sponsor
Modification(s)
|
| Name |
Intas Pharmaceuticals Ltd |
| Address |
2nd floor, Chinubhai Centre, Ashram Road,Ahmedabad-380 009, Gujarat, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjay Phadke |
Deenanath Mangeshkar Hospital & Research Centre |
Erandwane, Pune-411004, Maharashtra, India
Pune
MAHARASHTRA |
09823262786
sanjay_phadke@hotmail.com |
| Dr Jay Kumbhani |
Manas Psychiatric hospital & deaddiction centre |
301, 3rd floor, Manthan point, Opp. Amisha hotel,Una pani road,395003, India
Surat
GUJARAT |
02612443327
jaykumbhani2001@yahoo.co.in |
| Dr Sachin Patkar |
Masina Hospital, |
Sant Savta Marg,
Behind Gloria Church,
Byculla,400027, India
Mumbai
MAHARASHTRA |
9821082802
drsachinpatkar@sify.com |
| Dr Bakul Buch |
Shri Hatkesh Health Foundation |
Opp Bhutnath Temple, College Road,362001,India
Junagadh
GUJARAT |
0285-2654067
bakulbuch@gmail.com |
| Dr Vaishal Vora |
Sneh Clinic |
Flat no. 301-2-3,Nakshatra Complex, Canara bank road,
Above HDFC bank,Maninagar cross road, Maninagar,
380008,India
Ahmadabad
GUJARAT |
07925463963
vnvora@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Clinical Ethics Forum,Sai Prasad, 1st Floor, 125/A, Sion (West), Mumbai- 400 022 |
Approved |
| Independent Ethics Committee, 57 Brahmin Mitra Mandal Society, B/W Paldi Bus Stop and Jalaram Mandir, Paldi, Ahmedabad-380 006 |
Approved |
| Independent Ethics Committee, 57 Brahmin Mitra Mandal Society, B/W Paldi Bus Stop and Jalaram Mandir, Paldi, Ahmedabad-380 006 |
Approved |
| Independent Ethics Committee, 57 Brahmin Mitra Mandal Society, B/W Paldi Bus Stop and Jalaram Mandir, Paldi, Ahmedabad-380 006 |
Approved |
| Institutional Ethics Committee,Deenanath Manageshkar Hospital and Research Centre, Erandwane, Pune-411004. |
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
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 four days followed by crossover for the next four days as per randomization schedule.
|
| Comparator Agent |
Seroquel® film coated tablets 300 mg(Each film coated tablet containing quetiapine 300 mg as quetiapine fumarate) |
Patients will be administered either Test or Reference product twice daily for the first four days followed by crossover for the next four days as per randomization schedule |
|
Inclusion Criteria
Modification(s)
|
| 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 Authorized Representative (LAR).
2.Schizophrenic patients, between 18 and 60years of age (inclusive).
3.Patient has a documented clinical diagnosis of schizophrenia (DSM IV-TR) on a stable dose of Quetiapine 600 mg per day for at least 10 days prior to screening.
4.Having a Body Mass Index (BMI) between 18 and 30 (inclusive), calculated as weight in kg / height in m2.
5.Not having any significant diseases or clinically significant abnormal findings except schizophrenia during screening, medical history, physical examination, laboratory evaluations, 12-lead ECG and X-ray chest (postero-anterior view) recordings.
6.The investigator must ensure that the respective hepatic, renal, haematopoietic, cardiac and respiratory functions are appropriate to include the patient in the study.
7.Able to comply with study procedures in the opinion of the investigator.
8.In case of female patient the serum pregnancy test at screening visit and urine pregnancy test at day 1 and day 5 (before dosing) must be negative. |
|
| 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 (Meeting the criteria for any other (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Axis I) 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. Smokers who smoke 10 or more than 10 cigarette/day or inability to abstain from smoking during the study.
6. The presence of clinically significant abnormal laboratory values during screening.
7. Donation of blood (1 unit or 350 mL) within 90 days prior to receiving the first dose of study medication or during the study.
Note: In case the blood loss is less than or equal to 200 mL; Patient may be dosed 60 days after blood donation.
8. A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV IgM antibodies.
9. Known case of HIV infection.
10. Supine blood pressure less than 110/70 mm Hg or pulse rate less than 60 or more than 100 beats per minute at screening.
11. Presence of cataract on Opthalmoscopic examination (slit lamp exam).
12. History of seizures.
13. History of agranulocytosis.
14. Patients having Hypertension or on any antihypertensive medication.
15. Patients with Diabetes mellitus or fasting blood glucose ≥ 126 mg/dl at screening visit.
16. 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.
17. 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.
18. Dementia related psychosis.
19. Pregnant or lactating females.
|
|
Method of Generating Random Sequence
Modification(s)
|
Other |
Method of Concealment
Modification(s)
|
Other |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Primary PK Parameters: Cmax,ss and AUC,ss |
NIL |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Secondary PK Parameters: Cmin,ss, Tmax, PTF and Css,av |
NIL |
|
Target Sample Size
Modification(s)
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
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|
N/A |
Date of First Enrollment (India)
Modification(s)
|
23/01/2010 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The multidose pharmacokinetics of Quetiapine are dose proportional within the proposed clinical dose range and Quetiapine accumulation is predictable upon multi dosing. In the present study, the relative bioavailability of Quetiapine film coated tablets 300 mg from the test formulation in comparison to the reference product Seroquel® film coated 300 mg tablets will be assessed under fasting conditions at steady state after multiple dose administration in Schizophrenic patients stabilized on Quetiapine 600 mg per day Rationale:The Sponsor has developed the test formulation. This study is being conducted to compare the bioavailability and characterise the pharmacokinetic profile of the Sponsors 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. 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. 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. Objective:To compare the bioavailability and characterise the pharmacokinetic profile of the Sponsors 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 and safety of the patients |