Trial intelligence / Profile preview

Safety and PK/PD of HYR-PB21 in Healthy Volunteers

NCT04169256Phase 1Completed

Sponsor
Fruithy Medical
Start
Mar 2020
Primary completion
Jul 2020
Modality
Small Molecules, Lipid-based Nanoparticles
Countries
1
01

Overview

Phase 1, randomised, double-blind trial in acute postoperative pain comparing HYR-PB21 & Placebo with Liposome Bupivacaine & Placebo (2 arms). Primary endpoints: Area under the plasma concentration-versus-time curve from time zero to last quantifiable concentration at 15 days, Area under the plasma concentration-versus-time curve extrapolated to infinity at 15 days and 8 more. Started Mar 2020; status: completed.

02

Drugs

HYR-PB21
03

Conditions

acute postoperative pain

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