Health Condition 1: F23- Brief psychotic disorder
Conditions
Interventions
Intervention1: Test Product 1: Aripiprazole for Extended-Release Injectable Suspension, 400 mg: 400 mg/vial (2.0 mL).
Pharmaceutical dosage form: Injection.
Strength: 400 mg.
Route: Intramuscular.
Fre
Sponsors
PLIVA Croatia Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant, non-lactating female subjects more than 18 and less than 63 years of age. 2. Patient with Body Mass Index between 18.5 and 35 kg/m2 3. Patient and patient’s legally acceptable representative (LAR) must demonstrate adequate decision-making ability to make an informed decision about participating in this study by providing written informed consent. 4. Patient with documented diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders – 5th edition (DSM-V) or latest version criteria. 5. Patient who is clinically stable and had no hospitalization for exacerbation of psychiatric symptoms in last 3 months before screening till randomization. 6. Patient who is currently stable on a regimen consisting of Aripiprazole prolonged/extended release injectable suspension every four weeks for at least 16 weeks (at least 4 doses) as judged by investigator prior to randomization. (Treatment phase criteria) 7. Adequate hematological, hepatic and renal parameters at screening and randomization. 8. Patients with Clinical Global Impression – Severity of illness (CGI-S) score of less than 5.
Exclusion criteria
Exclusion criteria: 1. Known or suspected allergy or hypersensitivity to aripiprazole or other constituents of the formulation. 2. Patients who are on active treatment with drugs that are known to be inducer or inhibitor of CYP3A4 and CYP2D6 enzymes and interact with Aripiprazole (see list of allowed and prohibited medications provided as separate Appendix II) 3. Subjects with history or at risk of venous thromboembolism as per investigator’s discretion. 4. Have a history of alcohol or drug-dependence during the 6-month period immediately prior to screening. 5. Subjects with a history of Neuroleptic Malignant Syndrome (NMS) or tardive dyskinesia while on treatment with atypical antipsychotics. 6. Subjects with dementia related psychosis. 7. Subjects with history or presence of seizures or other conditions that potentially lower the seizure threshold. 8. Patient with history or presence of pathological gambling and compulsive behavior.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic equivalence of two formulations (Test vs Reference) in relation to estimation of Aripiprazole 400 mg injection administered in Schizophrenia PatientsTimepoint: The pre-dose blood sample will be collected before Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 in each period. End of study treatment and safety follow-up: This will be conducted on 28 days (± 1 day) after the Dose 6 in Period II. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability by Laboratory abnormalities, Adverse EventsTimepoint: During the study period of 16 Months for each patient. | — |
Countries
India
Contacts
Public ContactMr Prafulla Pawar
Teva Pharm India Pvt. Ltd
Outcome results
None listed