Risperidone Long acting injection in patients with Schizophrenia.
- Conditions
- Health Condition 1: F209- Schizophrenia, unspecified
- Registration Number
- CTRI/2022/03/040709
- Lead Sponsor
- Mylan Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1.Patients having a clinical diagnosis of schizophrenia as per DSM V and on stabilized treatment with antipsychotic agents other than paliperidone or risperidone.
2.Patients with stable psychiatric symptoms as judged by the Investigator at the time of giving informed consent.
3.Patients with established tolerability to oral or injectable risperidone prior to dosing.
4.Male or non-pregnant, non-lactating female subjects
5.Patients must be between 18 and 65 years of age (inclusive)
Exclusion Criteria
1.Patients who are on active treatment with drugs that are known to interact with risperidone
2.Diseases:
a. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, genitourinary, musculoskeletal disease or malignancies unless deemed not clinically significant by the Investigator.
b. Parkinson’s disease, mood disorders, or seizure disorder.
c. Patients with dementia related psychosis.
d. Patients with clinically significant hyperprolactinemia or with possible prolactin dependent tumor.
e. Patients with blood dyscrasias.
f. Glomerular Filtration Rate (GFR) less than 60 ml per min as estimated using the Cockcroft-Gault equation.
3.Oral Risperidone and/or paliperidone and Risperidone long-acting injection within 3 months prior to study drug administration. Paliperidone palmitate injection - 1 month and 3 month product within 1 year and 18 months respectively prior to study drug administration.
4.Patients with score of 2 in two or more movements or a score of 3 or 4 in a single movement as per AIMS (Abnormal Involuntary Movement Scale)
5.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, including: bradycardia, cardiac arrhythmias, hypokalaemia or hypomagnesemia, concomitant use of other drugs that known to prolong the QTc interval
6.Allergy or hypersensitivity to risperidone, paliperidone, other related products, or any inactive ingredients.
7.Patients with confirmed novel coronavirus infection (COVID-19)
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the PK bioequivalence of Mylan’s Risperidone Long-Acting Injection, 12.5 mg/vial with Janssen’s Risperdal Consta®, 12.5mg/vial in patients with schizophrenia under fasting conditions. <br/ ><br>Assessed after Period 1 dosing through to Day 64 of Period 1 and after Period 2 dosing through to Day 64 of Period 2 <br/ ><br>Timepoint: In each period, patients will remain in the clinic from Day 1 (evening prior to <br/ ><br>dosing) until Day 2 (24 hours after dosing) and PK samples will be collected on <br/ ><br>Day 1 (pre-dose and at 1, 2, 4, 8, 12 hours) and on Day 2 (24 hours). <br/ ><br>Patients will visit the site for ambulatory PK sample collection on Day 3, Day 5, Day 8, Day 11, Day 15, Day 18, Day 21, Day 24, Day 27, Day 30, Day 32, Day 34, Day 36, Day 38, Day 40, Day 43, Day 50, Day 57, and Day 64 in each period <br/ ><br>
- Secondary Outcome Measures
Name Time Method TTo evaluate the safety and tolerability of Mylan’s Risperidone Long-Acting Injection, 12.5 mg/vial in patients with schizophrenia.Timepoint: Safety will be assessed throughout the study i.e., from signing of ICF to end of study visit (Day 64 of period 2)