Health Condition 1: null- Schizophrenia
Conditions
Interventions
Intervention1: Quetiapine 600 mg prolonged-release tablet of Pharmathen S.A., Greece: Patients will be administered either one tablet of Test product or three tablets of Reference product once daily f
Sponsors
Pharmathen S A
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men and women aged 18-65 years (both inclusive) having clinical diagnosis of schizophrenia (DSM IV-TR or later). 2. Have body mass index of 18.5 to 30kg/m2. 3. Schizophrenic patients who are already receiving quetiapine fumarate at a dose of 600 mg/day@ or at least 15 days prior to screening @NOTE:such as 3tab of 200mg per day or 2tab of 300mg per day or equivalent either with immediate release or prolonged release tablets. 4. Adequate hematological parameters, hepatic and renal function at screening defined by: • Total white blood cell count greater than 4000/c.mm • ANC greater than or equal 1500/mm3 • Platelet count greater than or equal 75,000/mm3 • Haemoglobin greater than or equal 9.0 gm/dl • Bilirubin less than or equal 1.5 X ULN (upper limit of normal) • AST/ ALT less than or equal 3 X ULN • S. creatinine less than or equal 1.5 X ULN or creatinine clearance greater than or equal 60ml/min 5. Sexually active women, unless surgically sterile (at least 6 months prior to Study drug administration) or postmenopausal women (amenorrhea for at least 12 consecutive months and other biological or physiological cause can be identified), must agree to 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) during the study period. And Sexually active women must have a negative pregnancy test (at screening, before check-in on day 0) as well as must be non-lactating at screening. 6. In case of male patients: Either partner or patient must agree to use an effective method of avoiding pregnancy during the study period. 7. 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.
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to the active substance (quetiapine) or to any of the excipients of study products. 2. Patients with dementia related psychosis. 3. Patient with history of exacerbation of schizophrenia within two months prior to screening and during the screening period. 4. Concurrent primary psychiatric (other than schizophrenia) or neurological diagnosis, including neurologic malignant syndrome, major depressive disorder, organic mental disorder, severe tardive dyskinesia, Parkinsonâ??s disease, history or presence of epilepsy or risk for seizures, history of multiple syncopal episodes or stroke. 5. History of suicidal tendencies (e.g. 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. 6. Patients with a history of Neuroleptic Malignant Syndrome (NMS). 7. Patients with known cardiovascular disease (e.g., heart failure, history of myocardial infarction or ischemia, conduction abnormalities, cardiomyopathy, myocarditis), cerebrovascular disease, or conditions that predispose the patient to hypotension (e.g., dehydration, hypovolemia, and treatment with antihypertensive medications). 8. History or presence of circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval, including: bradycardia, cardiac arrhythmias, hypokalemia or hypomagnesemia, concomitant use of other drugs that prolong the QTc interval; and presence of congenital prolongation of the QT interval (QTc > 450 ms). 9. Patients with clinically significant hyperprolactinemia or with possible prolactin dependent tumor. 10. Patients with history or presence of tardive dyskinesia, seizures or other conditions that potentially lower the seizure threshold, , idiopathic Parkinsonâ??s disease, cognitive and motor impairment. 11. A medical or surgical condition that might interfere with the absorption, metabolism or excretion of Quetiapine. 12. Have a history of alcohol or drug-dependence as per DSM-IV criteria during the 6-month period immediately prior to Screening. 13. Positive test results for urine drug scan (except for prescribed benzodiazepines) or breath alcohol test at baseline. 14. Presence of uncontrolled metabolic disorders including uncontrolled diabetes mellitus (Fasting blood glucose levels greater than or equal 160 mg/dl and HbA1c greater than or equal 8 %), Serum total cholesterol greater than or equal300 mg/dl and fasting serum triglyceride levels greater than or equal 300 mg/dl. 15. History/presence of venous thromboembolism or conditions that predispose the risk of embolism. 16. Presence of significant prostatic hypertrophy, intestinal obstruction or related conditions, increased intraocular pressure or narrow angle glaucoma 17. History or presence of urinary retention. 18. Patients with known hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucoseÂgalactose malabsorption. 19. Significant orthostatic hypotension at screening or before check-in on day 0; orthostatic hypotension will be considered when there is drop in systolic blood pressure of 20 mm Hg or more and/or diastolic blood pressure of 10 mm Hg or more on standing from supine measurements measu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate bioequivalence at steady-state of Quetiapine 600 mg prolonged-release tablet of Pharmathen S.A., Greece in comparison with SEROQUEL XR (Quetiapine prolonged-release tablets) 200 mg (3 tablets X 200 mg) by AstraZeneca Austria GmbH.Timepoint: Total of 42 blood samples each of 4 ml will be collected during the study for PK analysis. The pre dose blood sample will be collected within 5 minutes before dosing on days 4,5,6 in period I and days 10,11,12 in period II of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability profile of the study formulations.Timepoint: NA | — |
Countries
India
Contacts
Public ContactDrAshoka Kumar Singh
Veeda Clinical Research Pvt.Ltd.
Outcome results
None listed