| CTRI Number |
CTRI/2010/091/006114 [Registered on: 29/12/2010] |
| Last Modified On: |
22/02/2013 |
| 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 clinical trial to study Bioequivalence of two formulations of Quetiapine fumarate in Adult Patients suffering from schizophrenia. |
Scientific Title of Study
Modification(s)
|
A Randomizd, Open Labl, Balncd, Multicentre, 2-Trtmnt, 2-Period, 2-Sequence, Steady stt, Multiple dose, Crossovr, Bioequivalnc Study of Quetiapine fumarate tab 300mg mfg by IPCA Ltd. with Seroquel 300 mg of AstraZeneca Ltd., in Adult Pts of schizophrenia. |
| Trial Acronym |
Nil |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| ARL/CT/010/012 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Chirag Shah |
| Designation |
|
| Affiliation |
|
| Address |
"Astha Hospital", Akash Complex, Opp. Bhagwan Chambers, Nr. Maninagar Cross Road, Maninagar, Ahmedabad
Ahmadabad
GUJARAT
380008
India |
| Phone |
|
| Fax |
|
| Email |
chiragpsyche@yahoo.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Agam Shah |
| Designation |
Lead Research Coordinator |
| Affiliation |
Clinical Trials |
| Address |
Accutest Research Laboratories Private Limited, Opposite The Grand Bhagwati Hotel
Sarkhej-Gandhinagar Highway, Bodakdev
Ahmadabad
GUJARAT
380054
India |
| Phone |
079-40231600 |
| Fax |
079-40029317 |
| Email |
agam.shah@accutestindia.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Mr Prasann Bavania |
| Designation |
Senior Research Associate |
| Affiliation |
Clinical Trials |
| Address |
Accutest Research Laboratories Private Limited, Opposite The Grand Bhagwati Hotel
Sarkhej-Gandhinagar Highway, Bodakdev
Ahmadabad
GUJARAT
380054
India |
| Phone |
079-40231600 |
| Fax |
079-40029317 |
| Email |
prasann.bavania@accutestindia.com |
|
Source of Monetary or Material Support
Modification(s)
|
| CRO: Accutest Research Laboratories (I) Pvt. Ltd., India |
| SPONSOR: Ipca Laboratories Limited, India |
|
Primary Sponsor
Modification(s)
|
| Name |
Ipca Laboratories Limited |
| Address |
International House,
48, Kandivili Industrial Estate,
Kandivili West,
Mumbai 400067, Maharashtra, INDIA |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Ismail Pala |
108 - Rajvee Towers, |
Nr. Tube Company, ,Old Padra Road,-390020
|
+919825257004
dripala@gmail.com |
| Dr Chirag Shah |
Aastha Psychiatric Nursing Home Deaddiction Centre and Sex Therapy Clinic |
Akash Complex, Near Maninagar Cross Roads, Maninagar 380008
Ahmadabad
GUJARAT |
9824274744
chiragpsyche@yahoo.com |
| Dr Rajendra Anand |
Anand Hospital |
Anand Hospital,
Gh-4, Sector-16, B/h Dena Bank,
Gandhinagar (Gujarat - India)
Gandhinagar
GUJARAT |
079-23238853
drrajendraanand@yahoo.com |
| Dr. Gautam Amin |
Riddhi Hospital |
3 - Ellorapark, Opp. Indraprasth, ,Nr. Veg. Market, Race Course, -
|
+919825027455
gautamsamin@yahoo.com |
| Dr. Nehalkumar Shah |
Shivmm Hospital |
2nd Floor, Mansarovar Complex,,Ramnagar Chowk, Sabarmati,-380005
Ahmadabad
GUJARAT |
+919925049569
drnehalshah@indiatimes.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| "Siddhant", Independent Ethics Committee |
Approved |
| Independe Ethics Committee - Aaditya |
Approved |
| Maanav Health Foundation - Independent Ethics Committee (MHF IEC) - Dr. Gautam |
Approved |
| Maanav Health Foundation - Independent Ethics Committee (MHF IEC) - Dr. Ismail |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Schizophrenia, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Quetiapine 300mg tablets, AstraZeneca Pharmaceuticals, Ltd. |
One tablet twice a day. |
| Intervention |
Quetiapine 300mg tablets, IPCA Laboratories Ltd. |
One tablet twice a day. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient has a documented clinical diagnosis of schizophrenia (DSM IV-TR) on a stable dose of quetiapine 300 mg twice a day for at least 14 days prior to screening
2. Females and/or males patients aged 18 to 55 years (both inclusive)
3. Patients having a Body Mass Index (BMI) between 18 kg/m2 and 35 kg/m2 (both inclusive)
4. Patient and/or his/ her Legally Acceptable Representative are willing to give written informed consent for participation in the trial
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 (PA view if required) 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. Women of child-bearing potential and all men must agree to use a medically accepted method of contraception from screening, while receiving protocol-specified medication till end of study. Acceptable methods of contraception include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device (IUD), oral or injectable hormonal contraceptive, and surgical sterilization (e.g., hysterectomy or tubal ligation). Women of child-bearing potential who are not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating in the study;
8. Female patients of childbearing potential must have a negative serum pregnancy test (beta-HCG) at Screening |
|
| ExclusionCriteria |
| Details |
1. Known hypersensitivity or idiosyncratic reaction to quetiapine or lack of response to quetiapine fumarate as judged by the investigator
2. Current or relevant history of serious, severe or unstable psychiatric illness, meeting the criteria for any other (DSM-IV Axis I) except schizophrenia.
3. History of syncope or orthostatic hypotension or 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. 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 e.g. Abnormality in vital signs (systolic blood pressure <90 or >140mmHg or diastolic blood pressure <50 or >90 mmHg or heart rate <50 beats/min or >100 beats/min at screening, randomisation and at pre-dose vital signs).
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, Trifluperazine, Sertraline and centrally acting anticholinergic drugs.
6. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
7. Pregnancy or lactation
8. Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
9. Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
10. Substance abuse or alcohol dependence at enrollment (except dependence in full remission), as defined by DSM-IV criteria
11. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
12. Unstable or inadequately treated medical illness (e.g. angina pectoris, hypertension, congestive heart failure) as judged by the investigator
13. History of or evidence of significant brain malformation or neoplasm, head injury, cerebral vascular events, neurodegenerative disorder affecting the brain or prior brain surgery
14. Concomitant treatment with other psychotropic drugs (e.g. antidepressive agents, anticonvulsants, other neuroleptics such as Citalopram, Fluvoxamine, Oxcarbazepine, Clonazepam, Escitaopram, and Divalproex Sodium) except benzodiazepines or hypnotics
15. Patient reactive to HIV, HBSAg & Hepatitis C
16. History of seizure disorder
17. Hospitalisation for schizophrenia within 1 month before entering into the study
18. Previous treatment with any other study medication within the last 4 weeks prior to enrollment into this study.
19. Participation in another drug trial within 4 weeks prior enrollment into this study or current participation in another clinical trial.
20. A patient known to have Diabetes Mellitus (DM)
21. Donated blood within 90 days before enrollment in the study |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To characterize the Pharmacokinetic profile of test formulation relative to that of the reference and to assess their Bioequivalence. |
Multiple time points up to 12 hours on last day of each period (i.e. Day 05 and Day 10). |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To monitor the safety and tolerability of two formulations |
During the study period. |
|
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
Modification(s)
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
20/04/2011 |
| 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)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a Randomized, Open Label, Balanced, Multicentre, Two-Treatment, Two-Period, Two-Sequence, Steady state, Multiple dose, Crossover, Bioequivalence Study of Two formulations of Quetiapine fumarate tablet 300 mg in Adult Patients suffering from schizophrenia. It is expected that sponsors test formulation will show pharmacokinetics similar to that of the reference listed drug and will prove bioequivalent to the reference drug. The trial will be conducted in Indian patients only and within India only. First patient was enrolled in the study on April 20, 2011. |