drugset / Trial / NCT02784327
A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of PRF110 in Bunionectomy Surgery
NaSingle-groupOpen-labelTreatment
Summary
PRF110 is new extended release oily solution formulation of ropivacaine that is intended for local infiltration into surgical wounds. The purpose of this study is to determine the safety and early efficacy of PRF110 in bunionectomy surgery, to measure the pharmacokinetic profile of PRF110 over 72 hours and evaluate the duration of analgesia witnessed in the surgical setting.
Timeline
- Start
- 2016-08
- Primary completion
- 2017-04
- Completion
- 2017-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ropivacaine | Other / unclassified | — | Other |
Indications
No indication recorded.