Health Condition 1: null- Adult Schizophrenic Patients Already Receiving or Stabilized with Qetiapine
Conditions
Interventions
Intervention1: Quetiapine Fumarate 300 mg IR tablets manufactured by Amneal Pharmaceuticals: Twice daily for 5 days of test period
Control Intervention1: Seroquel® 300 mg tablets manufactured by Astra
Sponsors
Amneal Pharmaceuticals LLC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult schizophrenic patients with body mass index (BMI) between 18 and 35kg/m2, inclusive, and aged between 18 and 60 years, inclusive. on stable regimen with Quetiapine 300 mg IR preparation Q12h 2. Confirmed by a psychiatrist according to the Diagnostic and Statistical Manual IV (DSM IV) criteria 3. Able to comprehend the full nature and purpose of the study, including possible risks and adverse events; ability to co-operate with the investigator and to comply with the requirements of the entire study 4. Signed written informed consent prior to inclusion in the study witnessed by a legally acceptable representative or guardian 5. Should be otherwise healthy as determined by physical examination, medical history, and no significant abnormality in any of the laboratory parameters including ECG and Chest X-ray 6. Body weight ≥ 45kgs 7. Adequate hemoglobin i.e. ≥10gm/dL 8. Adequate renal function at screening as defined by Creatinine 1.5 X ULN for the clinical laboratory 9. Female patients of childbearing potential must be willing to use a reliable method of birth control, i.e. barrier method, intrauterine device, etc. during the study.
Exclusion criteria
Exclusion criteria: 1. Known to have significant orthostatic hypotension 2. Known to have tachycardia or tachyarrhythmia 3. Bouts of uncontrolled seizures 4. Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, idiopathic Parkinson¡¯s disease or Alzheimer¡¯s dementia 5. Used any investigational drug within 3 months before Screening 6. On anticoagulants 7. Blood donations/ losses within 60 days of Screening 8. history of arrhythmias, hypokalemia, hypomagnesemia, or congenital QT prolongation History of multiple syncopal episodes 9. History of alcoholism within 3 months prior to Screening 10. History of drug abuse or dependence within 3 months prior to Screening 11. A value at Screening is greater than 1.5 times the upper limit of reference range for AST, ALT, direct bilirubin, total triglycerides, or total cholesterol 12. Contraindications or hypersensitivity to the use of Quetiapine or related group of drugs 13. Class III heart failure with evidence of recent progression, or Class IV heart failure per NYHA functional classification system 14. Uncontrolled and untreated hypertension 15. Myocardial infarction or acute coronary syndrome within 6 months prior to Screening 16. Significant pre-existing gastrointestinal co-morbidities that would preclude compliance with oral medication. 17. History of suicidal tendencies 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 18. Uncontrolled and un-treated diabetes mellitus 19. An unusual or abnormal diet, for whatever reason e.g. religious fasting 20. Smoking¡Ý 9 cigarettes/beedies per day 21. With bleeding disorders 22. On treatment with alpha adrenergic receptor blocking agents 23. Pregnant females as determined by positive serum or urine hCG test at Screening or prior to the first dose of study medication (Day 1) 24. Lactating female 25. On class 1A antiarrhythmics, class III antiarrhythmics, antipsychotics, antibiotics, other drugs associated with QT prolongation 26. On drugs which are enzyme inducer or inhibitors of CYP450 3A4, 5, and 7.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. AUC0-tau: Area under the plasma concentration to time curve over the steady state dosing interval. 2. Cmax-ss: Maximum concentration over the steady state dosing interval. 3. Cmin-ss: Minimum concentration over the steady state dosing interval.Timepoint: Dosing interval on day 5 and day 10. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Css-avg: Average concentration over the steady state dosing interval. 2. Percentage fluctuation: [Cmax-ss ? Cmin-ss / Css-avg] x 100 3. Tmax: Time of maximum measured plasma concentration over the steady state dosing interval. 4. Safety and tolerability as assessed by reported adverse eventsTimepoint: 1, 2 and 3 - Dosing interval on day 5 and day 10. 4 - throughout the study period | — |
Countries
India
Contacts
Public ContactMr Prasann Bavania
Accutest Research Laboratories Pvt. Ltd.
Outcome results
None listed