NCT02091388

Bioavailability of LY03004 and Risperdal® Consta®

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Schizophrenia
• Schizoaffective Disorder

Interventions

Type	Name	Description
DRUG	LY03004
DRUG	Risperdal® Consta®

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2014-03-19
• Last updated: 2015-03-04

Locations

10 sites across 1 country: United States