drugset / Trial / NCT02086786

Pharmacokinetics and Tolerability Study of Risperidone ISM® in Schizophrenia

NCT02086786

Phase 2 Completed 70 enrolled Rovi Pharmaceuticals Laboratories
RandomizedParallel-groupOpen-labelTreatment

Summary

To characterize the pharmacokinetics (PK) of the injectable intramuscular (IM) long-acting formulation (in situ microparticle, ISM) of risperidone over four IM injections in the gluteal and deltoid muscle at 28-day intervals and at one dose strength (75 mg) in patients with schizophrenia.

Timeline

Start
2014-03
Primary completion
2015-03
Completion
2015-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Risperidone Other / unclassified 75 mg Intramuscular

Indications