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Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant

NCT02232178 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2020-10-20

Study results available
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Summary

Assess the pharmacokinetic profile of 2 doses of the XaraColl® implant after open laparotomy hernioplasty and assess the relative bioavailability of Xaracoll compared to a local bupivacaine infiltration.

Conditions

  • Hernioplasty

Interventions

DRUG

2 100mg Xaracoll implants

DRUG

3 100mg Xaracoll implants

DRUG

150mg Bupivacaine HCl injection

Sponsors & Collaborators

  • Premier Research Group plc

    collaborator UNKNOWN

  • Innocoll

    lead INDUSTRY

Principal Investigators

  • Gwendolyn Niebler, D.O. · Innocoll

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-20
Primary Completion
2015-02-23
Completion
2015-03-23

Countries

  • United States

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 NCT02232178 on ClinicalTrials.gov