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Single Ascending Dose Study of Two Liquidia Bupivacaine Formulations

NCT02982889 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2017-08-24

No results posted yet for this study

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.

Conditions

  • Acute Pain

Interventions

DRUG

LIQ865A bupivacaine formulation

single subcutaneous injection in medial calf

DRUG

LIQ865B bupivacaine formulation

single subcutaneous injection in medial calf

DRUG

Diluent for LIQ865

Sterile diluent composed of 12.5mg/g sodium hyaluronate, 5.8mg/g sodium chloride, 1mg/g polysorbate 80, 6.1mg/g Tris base, in sterile water for injection - single subcutaneous injection

DRUG

0.5% bupivacaine hydrochoride

single subcutaneous injection

Sponsors & Collaborators

  • Premier Research Group plc

    collaborator UNKNOWN

  • Liquidia Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Mads U Werner, MD · Multidisciplinary Pain Center, Rigshospitalet

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02982889 on ClinicalTrials.gov