Health Condition 1: null- Schizophrenia
Conditions
Interventions
Intervention1: Test Product A-
WCK9003 Paliperidone Palmitate Intramuscular Injection 156 mg: Wockhardt Limited, India
Intervention2: Test Product B-WCK9003 Paliperidone Palmitate Intramuscular Inject
Sponsors
Wockhardt Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Written informed consent for participation in the study by the patient and patientâ??s legal acceptable representative (LAR). 2) Schizophrenic patients between 18.0 years and above. 3) Patients who are stabilized on Paliperidone extended release tablet 9mg once a day (atleast 8 consecutive doses before IP administration). 4) Patients have a documented clinical diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), as confirmed by the investigator. 5) Not having any significant diseases or clinical significant abnormal findings except schizophrenia during screening, medical history, physical examination, laboratory evaluation, which may prevent to administer Paliperidone or Resperidone. 6) Able to comply with study procedures in the opinion of the investigator.
Exclusion criteria
Exclusion criteria: 1) Current or relevant history of serious, severe or unstable psychiatric illness except schizophrenia. 2) History of neuroleptic malignant syndrome, tardive dyskinesia, or any malignancy. 3) Elderly patients with dementia-related psychosis treated with antipsychotic drugs 4) Patient on different antipsychotic treatment and unable to shift on Paliperidone oral therapy. 5) Have a DSM-IV diagnosis of alcohol or substance dependence, with the exception of nicotine or caffeine dependence. 6) Be involuntarily-hospitalized or plan to undergo surgery/procedures during the course of the study 7) Patient has taken the following prohibited medications: Strong CYP3A4/P-glycoprotein (P-gp) inducers (e.g., carbamazepine, rifampin, St Johnâ??s wort) barbiturates within 14 days prior to randomization. 8) Have current thoughts of suicide (suicidal ideation) or violent tendencies at the time of screening. 9) Patient with any condition which in the opinion of the investigator makes the patient unsuitable for inclusion. 10) Personal / family history of allergy or hypersensitivity to Paliperidone or risperidone or its congeners or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator would compromise the safety of the patient or the study. 11) Evidence of impairment of renal, hepatic, cardiac, lungs or gastrointestinal function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess bioavailability of WCK9003 Paliperidone Intramuscular Injection of Wockhardt Ltd., India compared with INVEGA SUSTENNA® (paliperidone palmitate) extended-release injectable suspension of Janssen Pharmaceuticals, Inc. USA, in adult patient of Schizophrenia, stabilized with Paliperidone.Timepoint: Pre-dose: 00 hours Post-dose sample on day: 02, 04, 06, 08, 09, 10, 11, 12, 13, 14, 15, 16, 18, 20, 24, 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor adverse events and ensure safety of the patients. Exploratory Analysis of pharmacokinetic parameters. Timepoint: NAP | — |
Countries
India
Contacts
Public ContactDr Nilesh Patel
Wockhardt Ltd
Outcome results
None listed