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
* 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Woodland International
Little Rock, Arkansas, United States
Collaborative Neuroscience Network LLC
Long Beach, California, United States
Neuropsychiatric Research Center of Orange County
Orange, California, United States
Cmax, Tmax, for Relative bioavailability of LY03004 compared to Risperdal® Consta®
Time frame: 113 Days
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 113 Days
The change of the PANSS score for the Preliminary efficacy of LY03004
Time frame: 113 Days
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