drugset / Trial / NCT02055287
Pharmacokinetic and Safety Study of LY03004 in Stable Patients With Schizophrenia or Schizoaffective Disorder
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2013-03
- Primary completion
- 2014-06
- Completion
- 2014-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Risperidone | Other / unclassified | 12.5 mg | Intramuscular |
| Subject | Risperidone | Other / unclassified | 25 mg | Intramuscular |
| Subject | Risperidone | Other / unclassified | 37.5 mg | Intramuscular |
| Subject | Risperidone | Other / unclassified | 50 mg | Intramuscular |