Health Condition 1: null- Schizophrenia
Conditions
Interventions
Intervention1: Paliperidone Palmitate Extended-Release Injectable Suspension
Mylan Laboratories Limited, India: Dose:156 mg
Route of Administration: IM
28 Days Cycle
Control Intervention1: INVEGA SUS
Sponsors
Mylan Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: Subjects who qualify for the study should meet the following 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. 3.Subjects who are clinically stable and no hospitalization for exacerbation of psychiatric symptoms during 3 months before screening and randomization. 4.Subjects with adequate renal function defined as creatinine clearance (Cockcroft-Gault Equation,) more than or equal to 80 mL/min. 5.Adequate hematological parameters at screening and randomization defined by: •Total white blood cell count more than or equal to 4000/mm3 •ANC more than or equal to 1500/mm3 •Platelet count more than or equal to 100,000/mm3 •Hemoglobin more than or equal to 9.0 gm/dl 6.Adequate hepatic function at screening and randomization as defined by: •Bilirubin less than 1.5 X ULN •AST & ALT less than 5 X ULN 7.Agree to comply with the visit schedule and other requirements of the study.
Exclusion criteria
Exclusion criteria: Subjects must not be enrolled in the study if they meet any one of the following 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 atypical 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 the use of drugs that prolong the QTc interval 5.Subjects with known cardiovascular disease (e.g., heart failure, history of myocardial infarction or ischemia, conduction abnormalities), cerebrovascular disease, or conditions that predispose the subject to hypotension (e.g., dehydration, hypovolemia, and treatment with antihypertensive medications). 6.Subjects with clinically significant hyperprolactinemia or with possible prolactin dependent tumor. 7.History of severe hepatic impairment and drug induced leukopenia/ neutropenia/ agranulocytosis. 8.Subjects with Clinical Global Impression - Severity of illness (CGI-S) score of 5 or more. 9.Subjects with history or presence of tardive dyskinesia, seizures or other conditions that potentially lower the seizure threshold, idiopathic Parkinsonâ??s disease, cognitive and motor impairment. 10.Subjects who are on active treatment with drugs that are known to interact with paliperidone. 11.Have a history of alcohol or drug-dependence as per DSM-V criteria during the 6-month period immediately prior to screening. 12.Subjects with clinically significant laboratory investigations as per the investigatorâ??s judgment. 13.Attempted suicide within 12 months before screening or are at imminent risk of suicide or violent behaviour as clinically assessed by the investigator. 14.Treatment with any of the following therapies: •Injection of risperidone long acting injection within 6 weeks before screening. •Electroconvulsive therapy within 3months prior to screening. •Clozapine within 3 months before screening. •Nonselective or irreversible monoamine oxidase inhibitor (MAOI) antidepressants within 30 days before screening. •Other antidepressant agents, unless subject had been on a stable dose for at least 3 months before screening and plans on remaining on that same exact regimen for the entire duration of the study. •Mood stabilizers, including lithium and all anticonvulsants, beta-blockers, and anti-parkinsonian medication. Unless subjects on a stable dose for at least 3 months before screening and expect to remain on that same exact regimen throughout the duration of the study. 15.Subjects who are: •Pregnant •Breast feeding •Male or female of childbearing potential unwilling to use adequate methods of contraception throughout the study. •Subjects whom 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. •Subjects with known positivity for human immunodeficiency virus (HIV), HBsAg or HCV. 16.Participation in any interventional clinical study within the past 90 days of randomization. 17.History of difficulty with donating blood or difficulty in accessibility of veins. 18.D
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the bioequivalence of Mylanâ??s Paliperidone Palmitate extended-Release Injectable Suspension with Janssenâ??s INVEGA SUSTENNA® in subjects with schizophrenia.Timepoint: After 24 Week ( post dose 6 total 19 PK sample assessment ) | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of Paliperidone Palmitate Extended-Release Injectable Suspension of Mylan Laboratories Limited, India in subjects with schizophrenia.Timepoint: To evaluate the safety and tolerability of Paliperidone Palmitate Extended-Release Injectable Suspension of Mylan Laboratories Limited, India in subjects with schizophrenia. | — |
Countries
India
Contacts
Public ContactMr Prasann Bavania
Cliantha Research Limited
Outcome results
None listed