Single Ascending Dose Study of Two Liquidia Bupivacaine Formulations
Status:
Completed
Trial end date:
2017-04-26
Target enrollment:
Participant gender:
Summary
This study is designed to assess and characterize the safety and tolerability profile of
LIQ865A and LIQ865B formulations compared to diluent or aqueous bupivacaine hydrochloride
when infiltrated into a defined area of the medial calf, and to characterize bupivacaine
plasma pharmacokinetic (PK) and pharmacodynamic (PD) profiles after a single dose of LIQ865A
or LIQ865B, and to determine the individual plasma concentration/time curves and mean PK
parameters of each product.