drugset / Trial / NCT00653406

A Pharmacokinetic and Safety Study of Risperidone Long Acting Injectable in Schizophrenic Patients

NCT00653406

Phase 1/2 Completed 29 enrolled Janssen Pharmaceutical K.K.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to explore the pharmacokinetic profile and safety after biweekly (every 2-week) intramuscular (IM) injections (6 injections) of risperidone long acting injectable 25, 37.5, or 50 mg/dose in schizophrenic patients. The efficacy of the study medication will also be assessed.

Timeline

Start
2002-11
Primary completion
Completion
2003-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Risperidone Other / unclassified 25 mg Intramuscular
Subject Risperidone Other / unclassified 37.5 mg Intramuscular
Subject Risperidone Other / unclassified 50 mg Intramuscular

Indications