Health Condition 1: F209- Schizophrenia, unspecified
Conditions
Interventions
Intervention1: Risperidone Long Acting Injection 25 mg/vial: Risperidone Long Acting Injection administered intramuscularly. every 14 days for 5 doses
Control Intervention1: Janssen’s Risperdal Consta
Sponsors
Mylan Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: Subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise 1. Male or non-pregnant, non-lactating female between 18 and 65 years of age. 2. Subjects with BMI 18 to 35 kg/m2 3. Diagnosed with schizophrenia or Bipolar I disorder as per DSM-V criteria 4. Subjects with stable psychiatric symptoms 5. Currently stable on a regimen consisting of risperidone long-acting injection 6. Subjects with Clinical Global Impression - Severity of illness (CGI-S) score less than or equal to 4 7. Subjects with adequate hematological parameters 8. Subjects with adequate hepatic function 9. Subjects with Negative HIV, hepatitis B antigen, hepatitis C antibody, RPR or VDRL test 10. Subjects with negative urine drug screen 11. Subjects with negative X-ray for tuberculosis
Exclusion criteria
Exclusion criteria: Subject candidates must not be enrolled in the study if they meet any of the following criteria: 1. Subjects with Known or suspected allergy or hypersensitivity to risperidone, paliperidone or similar drugs. 2. Diagnosis of alcohol or substance abuse during the 6-month period. 3. History or current presence of any significant or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular disease, organic mental disorder), renal, hepatic, hematologic, endocrine, immunologic, or other systemic disease. 4. History of uncontrolled diabetes, significant orthostatic hypotension uncontrolled hypertension, Parkinson’s disease, mood disorders or seizure disorder. 5. Subjects with dementia related psychosis. 6. Hospitalization due to exacerbation of psychiatric symptoms 7. Subjects with renal function abnormality. 8. Subjects with clinically significant hyperprolactinemia or with possible prolactin dependent tumor. 9. Subjects with blood dyscrasias. 10. Received Electroconvulsive Therapy (ECT) 11. Subjects with suicidal ideation score of 4 or 5 on Columbia Suicidal Severity Rating Scale. 12. Subjects who are on active treatment with drugs that are known to interact with risperidone. 13. History of neuroleptic malignant syndrome or tardive dyskinesia. 14. 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 15. Male or female of childbearing potential unwilling to use adequate method of contraceptive precautions throughout the study. 16. Subjects with clinically significant laboratory investigations as per the investigator’s judgment. 17. Any food allergy, intolerance, restriction or special diet 18. Participation in any interventional clinical study 19. History of difficulty with donating blood or difficulty in accessibility of veins. 20. Donation of blood
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the bioequivalence of Mylan’s Risperidone Long Acting Injection, 25 mg/vial with Janssen’s Risperdal Consta®, 25 mg/vial in subjects with schizophrenia or bipolar I disorder under fasting conditionsTimepoint: After 5th dose of period I and 3rd and 5th Dose of period II | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of Mylan’s Risperidone Long Acting Injection 25 mg/vial in subjects with schizophrenia or bipolar I disorder.Timepoint: Safety will be assessed throughout the study, i.e., from signing of ICF to end of study visit | — |
Countries
India
Contacts
Public ContactMr Hitesh Maheshwari
Cliantha Research Limited
Outcome results
None listed