NCT03527186

Comparative Bioavailability of Risperidone

An Open-Label, One-Sequence Study to Evaluate the Steady-State Comparative Bioavailability of Intramuscular Risperidone ISM® and Oral Risperidone

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Rovi Pharmaceuticals Laboratories · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, one sequence study to evaluate the steady-state comparative bioavailability of 100 mg Risperidone ISM® injectable every 4 weeks compared to once daily 4 mg oral risperidone in subjects with schizophrenia stabilized on oral risperidone treatment.

Detailed description

This is an open-label, 1-sequence study in subjects who are on stable oral risperidone treatment. The study consists of a screening visit, 1 treatment period with inpatient and outpatient visits, and a follow-up visit. Subjects who are on existing oral risperidone treatment (4 mg) will continue the oral regimen for 1 week to achieve steady-state concentrations of risperidone. Following the oral risperidone treatment, a single intramuscular (IM) dose of 100 mg risperidone ISM® will be administered deeply into the gluteal muscle. A total of 4 IM doses will be given that will be separated by 4 weeks. Safety assessments and pharmacokinetic (PK) sampling will be performed on each dosing day and each outpatient visit. A final follow-up visit will take place to assess each subject for safety and to obtain PK samples. Approximately 58 subjects will be enrolled, with the intent to complete 41 subjects. Fifty-eight subjects were estimated for enrollment based on 41 completers assuming an approximate drop-out rate of 30%. The primary objective of this study is to evaluate the steady-state comparative bioavailability of 100 mg risperidone ISM® injectable every 4 weeks compared to once daily 4 mg oral risperidone in subjects with schizophrenia stabilized on oral risperidone treatment. The secondary objective of this study is to evaluate the safety and tolerability of 100 mg risperidone ISM® injectable every 4 weeks compared to once daily 4 mg oral risperidone in subjects with schizophrenia stabilized on oral risperidone treatment.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Risperidone ISM® 100 mg	100 mg of risperidone ISM® administered every 4 weeks

Timeline

• Start date: 2018-07-09
• Primary completion: 2019-03-23
• Completion: 2019-04-06
• First posted: 2018-05-17
• Last updated: 2021-12-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study