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Pharmacokinetic and Safety Study of LY03004 in Stable Patients With Schizophrenia or Schizoaffective Disorder — LY03004SAD  

Schizophrenia Clinical Trial

Official title:
An Open-Label, Single Ascending Dose Pharmacokinetic and Safety Study of LY03004 Following Escalating Single Intramuscular Injection in Stable Patients With Schizophrenia or Schizoaffective Disorder

Clinical Trial Summary

The purpose of this study is to characterize the pharmacokinetics (PK) of LY03004 following an escalating single intramuscular injection at 12.5, 25, 37.5, or 50 mg; and to evaluate the safety and tolerability and preliminary efficacy of LY03004 following intramuscular injection.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02055287
Study type Interventional
Source Luye Pharma Group Ltd.
Contact
Status Completed
Phase Phase 1
Start date March 2013
Completion date June 2014
View Details
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