drugset / Trial / NCT02411526

Safety and PK Trial With Injectable ZX003 (Risperidone-SABER®) Compared to Risperdal® Consta® in Stable Schizophrenia

NCT02411526

Phase 1 Completed 60 enrolled Zogenix, Inc.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, multiple dose, PK and safety study in patients with chronic, stable schizophrenia or schizoaffective disorder.

Timeline

Start
2015-02
Primary completion
2015-09
Completion
2015-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Risperidone Other / unclassified 60 mg Subcutaneous
Comparator Risperidone Other / unclassified 90 mg Subcutaneous
Comparator Risperidone Other / unclassified 120 mg Subcutaneous
Comparator Risperidone Other / unclassified Intramuscular
Comparator Risperidone Other / unclassified 2 mg Oral