Health Condition 1: F208- Other schizophrenia
Conditions
Interventions
Intervention1: Quetiapine 400 mg prolonged release tablets
Manufactured by Krka d d Slovenia EU: The study will consist of two periods Eligible patients will be administered test or reference drug
Sponsors
Krka d d Slovenia
AXIS Clinicals Limited
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. Adult schizophrenic patients with body mass index (BMI) between 18 to 30 kg/m2 and aged between 18 to 60 years (both inclusive) who are already receiving quetiapine 400 mg as SR/PR tablet formulation per day. 2. Patient is on for quetiapine 400 mg as SR/PR tablet formulation therapy and has been taking a stable dose of Quetiapine 400 mg as SR/PR tablet formulation per day for at least one month before enrolment in the study. 3. Patient should be on quetiapine 400 mg SR/PR therapy only. 4. Patient confirmed with Schizophrenia by a psychiatrist according to the Diagnostic and Statistical Manual V (DSM V) criteria. 5. Patient provided informed consent prior to inclusion in the study also witnessed and signed by a legally acceptable representative. 6. Patient should have no clinically significant abnormality in any of the laboratory parameters including ECG and Chest X-ray (P/A view) as per the discretion of Principal Investigator. 7. Patient having adequate hematologic reserve at screening as per principal investigator assessment. 8. Patient having adequate and stable hepatic function and renal, hematopoietic, cardiac and respiratory function at screening as per principal investigator assessment. 9. Patient is nonsmoker and nonalcoholic. 10. Female patient of childbearing potential must be willing to use a reliable method of birth control as directed by study physician. 11. Female patient of childbearing potential must have a negative serum pregnancy test at screening. 12. Patient is able to communicate and cooperate with the Investigator and his staff.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Patient had 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. 2. Absolute neutrophil count 3. Patient with seated systolic blood pressure lower than 110 or above 140 mm of Hg, diastolic blood pressure lower than 60 or above 90 mm of Hg and seated heart rate less than 60 or above100 beats per minute at screening. 4. Patient has concurrent neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, cerebrovascular disease, idiopathic Parkinsonâ??s disease or Alzheimerâ??s dementia. 5. Patient with history of granulocytopenia or myeloproliferative disorder, either drug-induced or idiopathic. 6. Patient who is pregnant or lactating. 7. Patient found to positive for HIV/HCV/ HBsAg. 8. Patient participation in a clinical drug study or bioequivalence study / Patient donated blood/had blood loss ( >150ml) within 90 days prior to study participation. 9. Patient had history of multiple syncopal episodes. 10. Patient known to have significant orthostatic hypotension (i.e., a drop in systolic blood pressure of 30mm Hg or more and/or a drop in diastolic blood pressure of 20mm Hg or more on standing). 11. Patient had history of drug abuse or dependence within 3 months prior to Screening. 12. Patient is having contraindications or hypersensitivity to the use of Quetiapine and any of the excipients of the study drugs or related group of drugs. 13. QTc prolongation >450 milliseconds for men and >470 milliseconds for women. 14. Patient had Class III heart failure with evidence of recent progression (worsening dyspnea, etc), or Class IV heart failure per NYHA functional classification system. 15. Patient had uncontrolled and untreated hypertension and /or Diabetes. 16. Patients using medication for Hypertension and/or Diabetes. 17. Patient had myocardial infarction or acute coronary syndrome within 6 months prior to screening. 18. Patient had significant pre-existing gastrointestinal co-morbidities that would preclude compliance with oral medication (e.g. chronic diarrhea, inflammatory bowel diseases, constipation). 19. Patient had bleeding disorders and is on anticoagulant therapy. 20. Patient on treatment with alpha adrenergic receptor blocking agents (Prazosin, Terazosin, Doxazosin). 21. Patient is unable to communicate with the investigator. 22. Patient consumed grape fruit (mosumbi/sweet lime) juice within the 48 hours prior to study check-in. 23. Patient had history of difficulty with donating blood or difficulty in accessibility of veins or difficulty in swallowing the tablet. 24. Patient with history of seizures. 25. Patient with risk factors for venous thromboembolism. 26. Patient with risk factors for pancreatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC Area under the plasma concentration time curve over the steady state dosing interval Cmax ss Maximum concentration over the steady state dosing interval C Concentration at the end of the dosing interval at steady state Venous pre dose blood sample at 0 will be collected within 5 minutes prior to dosing and post dose blood samples of 5 mL will be withdrawn at 050 100 150 200 250 300 350 400 500 600 700 800 900 1000 1200 1600 1800 2400 hours post dose administrationTimepoint: Day 3 4 8 9 Predose will be collected within 5 minutes prior to dosing Complete PK sampling will be done on Day 5 including on Day 6 24 hour post dose sample will be done Period I and Day 10 including on Day 11 24 hour post dose sample will be done Venous pre dose blood sample at 0 will be collected within 5 minutes prior to dosing and post dose blood samples of 5 mL will be withdrawn at 050 100 150 200 250 300 350 400 500 600 700 800 900 1000 1200 1600 1800 2400 hours post dose administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Cminss Minimum concentration over the steady state dosing intervalCavg ss Average concentration over the steady state dosing interval Percentage fluctuation Cmax ss Cmin ss Cavg ss 100 Tmax ss Time of maximum measured plasma concentration over the steady state dosing interval Cpd predose concentration Predose concentrations determined before a dose at steady state Safety and tolerability as assessed by reported adverse events laboratory and clinical investigations and vital signs Timepoint: Day 3 4 8 9 Predose will be collected within 5 minutes prior Complete PK sampling will be done on Day 5 including on Day 6 24 h post-dose sample will be done Period I and Day 10 including on Day 11 24 h postdose sample will be done: Venous predose blood sample at 0.00 will be collected within 5 minutes prior to dosing and post dose blood samples 5 mL will be withdrawn at 050 100 150 200 250 300 350 400 500 600 700 800 900 1000 1200 1600 1800 2400 hours post dose administration | — |
Countries
India
Contacts
Public ContactDr Subhra Lahiri
AXIS Clinicals Limited
Outcome results
None listed