Health Condition 1: F209- Schizophrenia, unspecified
Conditions
Interventions
Intervention1: Risperidone long-acting injection, 25 mg: Patient will be administered IM injection of 25 mg every 14 days for a total of 5 doses for each treatment period (3 treatment period).
Control
Sponsors
Nanomi BV a Lupin group company
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willing to participate in the study; capable of reading, understanding, and providing voluntary written study specific informed consent in the designated language of the study site, and willing to comply with the study restrictions. The patientââ?¬•s legally authorized representative should review the information and sign the informed consent in case the patient has impaired cognitive function judged by the Investigator. 2. Male or female 18 to 65 years of age (inclusive) at the Screening visit. 3. Body Mass Index (BMI) 18.0ââ?¬â??35.0 kg/m2 (inclusive) at the Screening visit. 4. Chronic Schizophrenia as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). 5. Stable disease, as evidenced by a Clinical Global Impression-Severity scale (CGI-S) score ââ?°Â¤4. 6. For the Screening visit, the patient should be receiving a stable regimen of risperidone long-acting IM injection 7. Female patients of: ââ?¬Â¢childbearing potential, use adequate contraception:
Exclusion criteria
Exclusion criteria: Patients must not be enrolled in the study if they meet any of the following criteria: 1. Females who are pregnant, lactating, or planning to attempt to become pregnant. 2. Males with female partners who are pregnant, lactating, or planning to attempt to become pregnant. 3. Hospitalization for a psychotic episode within 6 months prior to the first dose of study medication. 4. Use of any antipsychotic medications during the specified restriction periods. 5. Clinically significant clinical laboratory abnormality, ECG, or other clinical findings on physical or neurological examination indicative of a clinically significant exclusionary disease). 6. History or current evidence of thrombotic or thromboembolism disorders, or have received anticoagulant or antithrombotic treatment 7. Fridericia-corrected QT interval (QTcF) >450 msec for males and >470 msec for females, or other clinically significant ECG findings (in the opinion of the Investigator or designee). 8. History of malignancy within the past five years except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer. 9. History or current evidence of clinically relevant cardiac arrhythmia, cardiovascular disease, uncontrolled hypertension, thyrotoxicosis, uncontrolled hypoactive thyroid disease (), parkinsonism, or hemorrhagic diathesis. 10. Posed a significant risk of a suicide attempt or violent behavior 11. Uncontrolled diabetes mellitus,; or Type 2 diabetes newly diagnosed during the screening period. 12. History of, or currently diagnosed with a convulsion disorder. 13. Electroconvulsive therapy within 2 months prior to the Screening visit. 14. Clinically significant laboratory value for white blood cell count ââ?°Â¤3 Ã?â?? 103 /Ã?¼L or an absolute neutrophil count ââ?°Â¤1.3 Ã?â?? 103 /Ã?¼L, or hemoglobin. 15.. 16. History of hypersensitivity or intolerance to risperidone), paliperidone, or any compound listed as being present in the study formulation. 17. History of Neuroleptic Malignant Syndrome, significant tardive dyskinesia, severe akathisia, or extra-pyramidal reactions such as dystonia 18. Positive hepatitis). 19. Positive test result for human immunodeficiency virus (HIV) antibody). 20. Positive results from screens for alcohol or substances of abuse . 21. Meet DSM-V criteria for moderate to severe alcohol use disorder. 22. Meet DSM-V criteria for moderate or severe substance use disorder. 23. History of difficulty with phlebotomy. 24. Donation of blood (1 pint or more) or plasma within 30 days prior to receiving the first dose of study medication. 25. Use of an investigational drug or product, or participation in a drug research study within 30 days prior to receiving the first dose of study medication, or 5 times the half-life of the investigational drug, whichever is longer. 26. Any condition which (in the opinion of the Investigator) would interfere with the patientââ?¬•s ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the patient if he or she took part in the trial. 27. Use of a strong inducer of CYP3A4. 28. Use of a strong inhibitor of CYP3A4 or CYP2D6. 29. Use of a monoamine oxidase inhi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the steady state relative bioavailability of a new risperidone long-acting injection product compared with Risperdal ConstaÃ?® following multiple-dose administration in patients with schizophreniaTimepoint: Based on PK parameters calculated for risperidone in plasma, following the 5th dose (after 8 weeks) in each treatment period and following the 3rd dose (4 weeks) in treatment periods 2 and 3. In addition to confirm achievement of steady state, one pre-dose blood sample will be collected prior to each dose in each treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of Lupin risperidone LAI compared with Risperdal ConstaÃ?® following multiple-dose administration in patients with schizophrenia.Timepoint: At each dose and end of each treatment period. Period ââ?¬â?? I: ECG and blood/Urine analysis will be performed at Screening, Randomization Day -1 and week 4. Period ââ?¬â?? II: ECG and blood/Urine analysis will be performed at 10th & 14th week. Period ââ?¬â?? III: ECG and blood/Urine analysis will be performed at 20th & 24th week. | — |
Countries
India
Contacts
Public ContactMr Hitesh Maheshwari
Cliantha Research Limited
Outcome results
None listed