Health Condition 1: F209- Schizophrenia, unspecified
Conditions
Interventions
Intervention1: Paliperidone palmitate Extended-Release Injectable Suspension 546 mg of Mylan Laboratories Limited, India: Paliperidone palmitate Extended-Release Injectable Suspension 546 mg.
Administ
Sponsors
Mylan Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Men or non-pregnant, non-lactating females aged 18-65 years (inclusive) having clinical diagnosis of schizophrenia. 2.Subjects with Body Mass Index (BMI) less than or equal to 35 but greater than or equal to 18 at screening and randomization. 3.Subjects who are already receiving a stable regimen of the 156 mg of monthly paliperidone palmitate extended release suspension or 546 mg of the three-month paliperidone palmitate extended release suspension via the intramuscular route prior to randomization. 4.Subjects with established tolerability to oral paliperidone/risperidone or injectable paliperidone prior to screening. 5.Subjects who are clinically stable and not hospitalized for exacerbation of psychiatric symptoms during 3 months before randomization. 6.Adequate hematological parameters at screening and randomization. 7.Adequate hepatic and renal function at screening and randomization. 8.Subject and LAR must demonstrate adequate decision-making ability to make a choice about participating in this study and provide written informed consent to participate. Agree to comply with the visit schedule and other requirements of the study
Exclusion criteria
Exclusion criteria: 1.History of known hypersensitivity to paliperidone, risperidone, or to any excipients in study medications. 2.Subjects with dementia related psychosis. 3.Subjects with a history of Neuroleptic Malignant Syndrome (NMS) while on treatment with antipsychotics. 4.History or presence of circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with use of drugs that prolong QTc interval 5.Presence of uncontrolled metabolic disorders. 6.Subjects with known cardiovascular disease. 7.Subjects with clinically significant hyperprolactinemia or with possible prolactin dependent tumor. 8.History of severe hepatic impairment or drug induced leukopenia/neutropenia/ agranulocytosis. 9.Subjects with Clinical Global Impression - Severity of illness (CGIS) score of 5 or more. 10.Subjects with history or presence of tardive dyskinesia, seizures, idiopathic Parkinsonâ??s disease, cognitive and motor impairment. 11.Subjects who are on active treatment with drugs that are known to interact with paliperidone. 12.Have a history of alcohol or drug-dependence as per DSM-V criteria during the 6-month period immediately prior to screening. 13.Subjects with clinically significant laboratory investigations as per the investigatorâ??s judgment. 14.Attempted suicide within 12 months before screening or are at imminent risk of suicide or violent behavior as clinically assessed by the investigator. 15.Male or female of childbearing potential unwilling to use adequate methods of contraception throughout the study. 16.Subjects who had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery, or whom have surgery scheduled during the course of the study. 17.Subjects with known positivity for human immunodeficiency virus (HIV), HBsAg or HCV. 18.Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product in the study. 19.Any reason which, in the opinion of the Principal Investigator or Co-Investigator, would prevent the subject from safely participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the bioequivalence of Mylanâ??s Paliperidone Palmitate Extended-Release Injectable Suspension with Janssenâ??s INVEGA TRINZA in subjects with Schizophrenia Timepoint: Day 360 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of Mylanâ??s Paliperidone Palmitate Extended-Release Injectable Suspension in subjects with schizophreniaTimepoint: Day 360 | — |
Countries
India
Contacts
Public ContactMr Hitesh Maheshwari
Cliantha Research Limited.
Outcome results
None listed