CTRI/2021/11/038048Not yet recruitingNot Applicable
A Randomized, Multicenter, Multiple-dose, Two-treatment, Single-period, Parallel, Steady-State Bioequivalence Study of Mylan’s Paliperidone Prolonged-release Suspension for Injection, 350 mg and Janssen-Cilag’sTrevicta® Prolonged-release Suspension for Injection, 350 mg in Subjectswith Schizophrenia.
Mylan Laboratories Limited17 sites in 1 country300 target enrollmentStarted: November 17, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Mylan Laboratories Limited
- Enrollment
- 300
- Locations
- 17
- Primary Endpoint
- To evaluate the bioequivalence of Mylan’s Paliperidone Prolonged-release Suspension for Injection 350 mg of Mylan Laboratories Limited, India with Janssen-Cilag’s Trevicta 350 mg (equivalent to 546 mg Paliperidone Palmitate) in subjects with schizophrenia.
Study Overview
Brief Summary
A bioequivalence study withPaliperidone Prolonged-releaseSuspension for Injection 350 mg insubjects with schizophrenia with the following objectives:
To demonstrate thebioequivalence of Mylan’s Paliperidone Prolonged-release Suspension forInjection 350 mg of Mylan Laboratories Limited, India with Janssen-Cilag’sTrevicta 350 mg (equivalent to 546 mg Paliperidone Palmitate) in subjects withschizophrenia
To evaluate the safety and tolerability of Mylan’sPaliperidone Prolonged-release Suspension for Injection, 350 mg in subjectswith schizophrenia.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified: 1.Male or on-pregnant, non-lactating female subjects between 18 and 65 years of age (both inclusive) 2.Patients having a clinical diagnosis of schizophrenia as per DSM V criteria.
- •3.Patients with established tolerability and responsiveness to oral paliperidone/risperidone or injectable paliperidone prior to screening 4.Subjects who are on a stable regimen of 350 mg three-month paliperidone palmitate prolonged-release suspension for injection (e.g. Trevicta® 350 mg) 5.Subjects who are clinically stable with no hospitalizations for exacerbation of psychiatric symptoms 6.Weight:Each subject is required to weigh at least 50 kg (110 lbs) for men and 48 kg (106 lbs) for women and have a Body Mass Index (BMI) value less than or equal to 35.0 kg/m2 but greater than or equal to 18.0 kg/m2.
Exclusion Criteria
- •Subject candidates must not be enrolled in the study if they meet any of the following criteria: 1.Institutionalized subjects. 2.Subjects with history of alcohol or drug-dependence as per DSM-V criteria 3.Subjects with ingestion of any alcoholic beverage within the 24 hours 4.Subjects with ingestion of risperidone long acting injection 5.Subjects with depot injection or implant of any drug other than hormonal contraceptive or hormone replacement therapy 6.Subjects currently being treated with Clozapine, monoamine oxidase inhibitor (MAOI) antidepressants, electroconvulsive therapy 7.Use of any medication, herbal supplement, or vitamin known to induce or inhibit hepatic enzyme activity 8.Subjects with dementia related psychosis 9.Subjects with Clinical Global Impression.
- •Severity of illness (CGI-S) score of 5 or more 10.Subjects with suicidal ideation 11.Subjects with a history of Neuroleptic Malignant Syndrome (NMS) 12.History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, genitourinary, musculoskeletal disease, uncontrolled metabolic diseases, clinically significant laboratory results or malignancies by the Principal Investigator or Medical Sub-Investigator. 13.Use of drugs that prolong the QTc interval, 14.Subjects with positive HIV, hepatitis B antigen, hepatitis C antibody, RPR or VDRL test 15.Subjects with positive urine drug screen 16.Subjects with history or presence of tardive dyskinesia, seizures idiopathic Parkinson’s disease, cognitive and motor impairment. 17.Subjects with donation or loss of blood or plasma 18.Subjects with participation in any interventional clinical study 19.Subjects with allergy or hypersensitivity to paliperidone, risperidone, other related products, or any inactive ingredients 20.Subjects has clinical signs and symptoms consistent with COVID-19 or had severe COVID-19.
Outcomes
Primary Outcomes
To evaluate the bioequivalence of Mylan’s Paliperidone Prolonged-release Suspension for Injection 350 mg of Mylan Laboratories Limited, India with Janssen-Cilag’s Trevicta 350 mg (equivalent to 546 mg Paliperidone Palmitate) in subjects with schizophrenia.
Time Frame: after 5th dose
Secondary Outcomes
- To evaluate the safety and tolerability of Mylan’s Paliperidone Prolonged-release Suspension for Injection, 350 mg in subjects with schizophrenia.(Safety will be assessed throughout the study , i.e., from signing of ICF to end)
Investigators
Study Sites (17)
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