| CTRI Number |
CTRI/2017/08/009291 [Registered on: 08/08/2017] Trial Registered Prospectively |
| Last Modified On: |
17/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Bioequivalence study of Quetiapine Fumarate extended release tablets EQ 400 mg base in Patients suffering from Schizophrenia |
|
Scientific Title of Study
|
A randomized, open-label, two-treatment, two-period, cross-over, multiple dose, steady state, multi-centre comparative bioequivalence study of Quetiapine Extended-Release Tablets, USP 400 mg manufactured by Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Rajoda, Ahmedabad, India for Amneal Pharmaceuticals, with SEROQUEL XR® (quetiapine fumarate extended release tablets) 400 mg manufactured by AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 in patients suffering from schizophrenia under fasting conditions. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ARL/CT/14/003 Version 01 Dated 29 May 2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajaykumar B Malle |
| Designation |
General Manager Clinical Trials |
| Affiliation |
Accutest Research Laboratories (I) Pvt Ltd |
| Address |
A77, Khairne MIDC, TTC Industrial Area,
Khairne, Navi Mumbai
Mumbai
MAHARASHTRA
400709
India |
| Phone |
27780718 |
| Fax |
27780720 |
| Email |
ajay.malle@accutestglobal.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajaykumar B Malle |
| Designation |
General Manager Clinical Trials |
| Affiliation |
Accutest Research Laboratories (I) Pvt Ltd |
| Address |
A77, Khairne MIDC, TTC Industrial Area,
Khairne, Navi Mumbai
Mumbai
MAHARASHTRA
400709
India |
| Phone |
27780718 |
| Fax |
27780720 |
| Email |
ajay.malle@accutestglobal.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hiren Gandhecha |
| Designation |
Project Manager Clinical Trials |
| Affiliation |
Accutest Research Laboratories (I) Pvt Ltd |
| Address |
Opp. The Grand Bhagwati,
S.G. Highway,
Bodakdev, Ahmedabad
Ahmadabad
GUJARAT
380059
India |
| Phone |
40231600 |
| Fax |
40029317 |
| Email |
hiren.gandhecha@accutestglobal.com |
|
|
Source of Monetary or Material Support
|
| Amneal Pharmaceuticals 50 Horse Block Road Brookhaven, NY 11719 |
|
|
Primary Sponsor
|
| Name |
Amneal Pharmaceuticals |
| Address |
50 Horse Block Road Brookhaven,
NY 11719
United States of America |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Accutest Research Laboratories I Pvt Ltd |
A-77, Khairne MIDC, TTC Industrial Area, Khairne, Navi Mumbai-400 709 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Timirkumar Chandrakant Shah |
Divyam Hospital |
Block No. 84, Palsana Cross Roads, National Highway No-8,Surat- 394315
Surat
GUJARAT |
9825137443
drtcshah@gmail.com |
| Dr Rajendra Someshwar Anand |
Kanoria Hospital & Research Centre |
Near Indira bridge, Hansol Gandhinagaer Highway, Bhat, Gandhinagar, Ahmadabad-382428
Ahmadabad
GUJARAT |
7923969274
drrajendraanand@yahoo.com |
| Dr Kishor Dudani |
Malpani Multispeciality Hospital |
SP-6, Vishwakarma Institutional Area, Road 1 Sikar Road, Jaipur- 302013
Jaipur
RAJASTHAN |
9887350168
dudanikishoredr@gmail.com |
| Dr Bakul Buch |
Shri Hatkesh Healthcare Foundation |
Saraswati Mandir Complex Near Bhutnath Temple, College Road Junagadh 362001
Junagadh
GUJARAT |
9825220330
bakulbuch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ethics Committee Divyam Hospital |
Submittted/Under Review |
| Hatkesh Healthcare Foundation Ethics Committee |
Submittted/Under Review |
| Institutional Ethics Committee Malpani Multispeciality Hospital |
Approved |
| Kanoria Ethics Committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
schizophrenia, (1) ICD-10 Condition: F209||Schizophrenia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Quetiapine Extended-Release Tablets, USP 400 mg Manufactured by Amneal Pharmaceuticals Pvt. Ltd. India for Amneal Pharmaceuticals. |
Patients will be housed for entire study period from study days 0 to 11 and will be administered IP under supervision of investigator/designee on all 10 study days i.e. period I – days 1 to 5 & period II – days 6 to 10. In morning of each study day, after overnight fast of at least 10 hours patient will be administered oral dose of single tablet of IP (Quetiapine Fumarate extended release tablets EQ 400 mg base as per site specific randomization schedule) with approximately 240 mL of water at ambient temperature in sitting position, under supervision of investigator/designee. Patients will be instructed not to chew or crush or bite the tablet but to consume it as a whole. |
| Comparator Agent |
SEROQUEL XR® (quetiapine fumarate extended release tablets) 400 mg Manufactured by AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 |
Patients will be housed for entire study period from study days 0 to 11 and will be administered IP under supervision of investigator/designee on all 10 study days i.e. period I – days 1 to 5 & period II – days 6 to 10. In morning of each study day, after overnight fast of at least 10 hours patient will be administered oral dose of single tablet of IP (Quetiapine Fumarate extended release tablets EQ 400 mg base as per site specific randomization schedule) with approximately 240 mL of water at ambient temperature in sitting position, under supervision of investigator/designee. Patients will be instructed not to chew or crush or bite the tablet but to consume it as a whole. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Either sex, aged 18 to 65 years (both inclusive) having clinical diagnosis of schizophrenia (DSM IV-TR)
2. Receiving a stable dose of Quetiapine Fumarate extended release tablets treatment for at least 1 month prior to randomization and is on Quetiapine Fumarate extended release tablets EQ 400 mg base once daily dosage at the time of screening.
3. Willing and able to comply with housing, restrictions and other protocol requirements as indicated by signed written informed consent witnessed by a legally acceptable representative.
4. Females of childbearing potential (who has not completed 1 year after menopause & have not gone through hysterectomy or bilateral tubal ligation) must have a negative pregnancy test (at screening, before randomization and before check-in to housing i.e., day 0) as well as must be non-lactating at screening and must agree to use an effective contraceptive method during study. |
|
| ExclusionCriteria |
| Details |
1. History of allergic reactions to Quetiapine or other component of the extended release formulation.
2. Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, alcoholic and other toxic psychoses, severe tardive dyskinesia, or idiopathic Parkinson’s disease.
3. History of suicidal tendencies (i.e., suicidal attempts) within the past 3 months prior to screening or immediate risk of harm to self or other at the time of screening, as judged by the investigator.
4. History of Neuroleptic Malignant Syndrome, cardiovascular disease [ischemic heart disease (including myocardial infarction), heart failure (including congestive heart failure or significant heart hypertrophy) or conduction abnormalities (including bradyarrythmia, congenital QT prolongation or family history of QT prolongation)], cerebrovascular disease, drug induced leucopenia/ neutropenia, seizures or with conditions that potentially lower the seizure threshold e.g. Alzheimer’s dementia
5. History of multiple syncopal episodes or presence of significant orthostatic hypotension at screening or before check-in to housing on day 0; Orthostatic hypotension will be considered when there is drop in systolic blood pressure of 30 mm Hg or more or diastolic blood pressure of 20 mm Hg or more on standing from supine measurements.
6. Current/ recent (within 3 months) history of uncontrolled epilepsy or risk for seizures
7. A medical or surgical condition that might interfere with theabsorption, metabolism or excretion of Quetiapine
8. Drug abuse or alcohol dependence in last 1 year period before enrolment (except dependence in full remission), as defined by DSM IV-TR criteria and as positive result in breath alcohol testing/ urine screen for drug of abuse (except for prescribed benzodiazepines).
9. Any of the following investigational abnormality in screening:
WBC count < 3000/mm3 (3.0x109
Absolute Neutrophil Count <1500/mm/l),3 (1.5x109)
Serum creatinine> 1.5 mg/dL /l),
QTc> 500 milliseconds (in ECG of screening or day 0)
SGOT/ SGPT >3 times Upper Limit of Normal range (ULN)
HbA1c> 9%
Reactive to anti-HIV, HBsAg, anti-HCV
10.Use of any of the following in the 14 days preceding enrolment including but not limited to:
Strong inhibitors of CYP3A4.
Strong inducers of CYP3A4.
Drugs associated with QT prolongation.
11. Participation in another clinical trial or use of other investigational product/ device within 4 weeks prior enrollment into this study.
12. Blood donation/blood loss exceeding 200 ml within 90 days prior to enrollment in the study.
13.Any condition/Abnormal baseline findings that in the investigators’ judgment might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study i.e., low expectation of compliance to dosing or expected changes in concomitant medication that may interfere in study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To characterize pharmacokinetic profile of test product (T) and reference Product (R) and assess their bioequivalence. |
01.00, 02.00, 03.00, 04.00, 04.50, 05.00, 05.50, 06.00, 06.50, 07.00, 07.50, 08.00, 09.00, 10.00, 11.00, 12.00, 14.00, 18.00 and 24.00 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety and tolerability of a multiple doses of Quetiapine Fumarate extended release tablets EQ 400 mg base in patients suffering from schizophrenia who are already on a stable regimen with Quetiapine Fumarate extended release tablets EQ 400 mg base once daily. |
Monitoring and Reporting of Adverse Events.
|
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/08/2017 |
| Date of Study Completion (India) |
03/10/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
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 present study aims to evaluate bioequivalence of Sponsor’s test formulation against corresponding reference product SEROQUEL XR® (quetiapine fumarate extended release tablets) 400 mg manufactured by AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850in patients suffering from schizophrenia who are already on a stable regimen with Quetiapine Fumarate extended release tablets EQ 400 mg base once daily. |