drugset
drugset / Trial / NCT02982889

Single Ascending Dose Study of Two Liquidia Bupivacaine Formulations

NCT02982889 ↗

Phase 1 Completed 29 enrolled Liquidia Technologies, Inc. Premier Research · collab
RandomizedFactorialQuadruple-blindBasic science

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.

Timeline

Start
2016-12-05
Primary completion
2017-03-23
Completion
2017-04-26

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 0.5 % Subcutaneous
Subject LIQ865A Unknown 150 mg Subcutaneous
Subject LIQ865A Unknown 600 mg Subcutaneous
Subject LIQ865B Unknown 150 mg Subcutaneous
Subject LIQ865B Unknown 600 mg Subcutaneous

Indications

No indication recorded.