To assess blood concentration of Paliperidone Prolonged Release Injectable Suspension at different times in patients with Schizophrenia following multiple doses
- Conditions
- Health Condition 1: F209- Schizophrenia, unspecified
- Registration Number
- CTRI/2021/11/038048
- Lead Sponsor
- Mylan Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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 Parkinsonâ??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
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the bioequivalence of Mylanâ??s Paliperidone Prolonged-release Suspension for Injection 350 mg of Mylan Laboratories Limited, India with Janssen-Cilagâ??s Trevicta 350 mg (equivalent to 546 mg Paliperidone Palmitate) in subjects with schizophrenia.Timepoint: after 5th dose
- Secondary Outcome Measures
Name Time Method To evaluate the safety and tolerability of Mylanâ??s Paliperidone Prolonged-release Suspension for Injection, 350 mg in subjects with schizophrenia.Timepoint: Safety will be assessed throughout the study , i.e., from signing of ICF to end <br/ ><br>of study visit (Day 420)