drugset / Trial / NCT01592110
A Safety and PK Study of Injectable Risperidone-SABER and the DosePro Delivery System in Patients With Schizophrenia
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase 1, open-label study to evaluate the safety and pharmacokinetics (PK) of three doses of risperidone-SABER, administered with a needle and syringe or via the DosePro Needle-Free Delivery System in patients with chronic, stable schizophrenia.
Timeline
- Start
- 2012-07
- Primary completion
- 2013-04
- Completion
- 2013-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | risperidone-SABER | Unknown | 25 mg | Subcutaneous |
| Subject | risperidone-SABER | Unknown | 50 mg | Subcutaneous |
| Subject | risperidone-SABER | Unknown | 100 mg | Subcutaneous |