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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY03004 25 mg | Experimental | 5 intramuscular injections 25 mg over 113 days |
|
| Risperdal® Consta® 25 mg | Active Comparator | 5 intramuscular injections 25 mg over 113 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY03004 | Drug |
| ||
| Risperdal® Consta® |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax, Tmax, for Relative bioavailability of LY03004 compared to Risperdal® Consta® | 113 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 113 Days | |
| The change of the PANSS score for the Preliminary efficacy of LY03004 | 113 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simon Li | Luye Pharma Group Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woodland International | Little Rock | Arkansas | 72211 | United States | ||
| Collaborative Neuroscience Network LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38244179 | Derived | Wang W, Wang X, Dong Y, Walling DP, Liu P, Liu W, Shi Y, Sun K. Population Pharmacokinetic Analysis to Support and Facilitate Switching from Risperidone Formulations to Rykindo in Patients with Schizophrenia. Neurol Ther. 2024 Apr;13(2):355-372. doi: 10.1007/s40120-024-00578-w. Epub 2024 Jan 20. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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|
| Long Beach |
| California |
| 90806 |
| United States |
| Neuropsychiatric Research Center of Orange County | Orange | California | 92868 | United States |
| Comprehensive Clinical Development | Washington D.C. | District of Columbia | 20016 | United States |
| Compass Research | Leesburg | Florida | 34748 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30308 | United States |
| CBH Health LLC | Rockville | Maryland | 20850 | United States |
| CRI LifeTree | Marlton | New Jersey | 08053 | United States |
| CRI LifeTree | Philadelphia | Pennsylvania | 19139 | United States |
| Community Clinical Research Inc | Austin | Texas | 78754 | United States |