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Bioavailability of LY03004 and Risperdal® Consta®

Schizophrenia Clinical Trial

Official title:
A Randomized, Open-Label, Parallel-Group Study to Assess the Relative Bioavailability of LY03004 and Risperdal® Consta® at 25 mg Following Multiple Intramuscular Injections in Stable Patients With Schizophrenia or Schizoaffective Disorder

Clinical Trial Summary

This study is to assess the bioavailability of LY03004 compared to Risperdal Consta as well as the evaluate the safety and tolerability and preliminary efficacy of LY03004 with repeat injections

Clinical Trial Description

- To assess the relative bioavailability of LY03004 compared to Risperdal® Consta® at 25 mg following multiple intramuscular injections at steady-state;

- To evaluate the safety and tolerability of LY03004 following repeated intramuscular injections

- To evaluate the preliminary efficacy of LY03004 following repeated intramuscular injections ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02091388
Study type Interventional
Source Luye Pharma Group Ltd.
Contact
Status Completed
Phase Phase 1
Start date September 2014
Completion date January 2015
View Details
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