drugset / Trial / NCT01592110

A Safety and PK Study of Injectable Risperidone-SABER and the DosePro Delivery System in Patients With Schizophrenia

NCT01592110 ↗

Phase 1 Completed 40 enrolled Zogenix, Inc.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase 1, open-label study to evaluate the safety and pharmacokinetics (PK) of three doses of risperidone-SABER, administered with a needle and syringe or via the DosePro Needle-Free Delivery System in patients with chronic, stable schizophrenia.

Timeline

Start
2012-07
Primary completion
2013-04
Completion
2013-04

Drugs

EvaluationDrugModalityDoseRoute
Subject risperidone-SABER Unknown 25 mg Subcutaneous
Subject risperidone-SABER Unknown 50 mg Subcutaneous
Subject risperidone-SABER Unknown 100 mg Subcutaneous

Indications