drugset / Trial / NCT02658357
Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The study will be a 6-month, open-label, multiple center study in approximately 50 stable subjects diagnosed with schizophrenia or schizoaffective disorder to evaluate the safety, tolerability, and pharmacokinetics of Risperidone and 9-OH-Risperidone following implantation of two or three, 300 mg Risperidone Implants.
Timeline
- Start
- 2015-10
- Primary completion
- 2017-08
- Completion
- 2017-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Risperidone | Other / unclassified | 600 mg | Other |
| Subject | Risperidone | Other / unclassified | 900 mg | Other |