MedTrace Logo

Pharmacokinetics, Relative Bioavailability and Safety of INL-001 Compared to Marcaine After Open Hernioplasty

NCT03234374 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2021-07-30

Study results available
· View outcomes & findings →

Summary

This is a multicenter randomized, single-blind, controlled study. The primary objectives of this study are to obtain the pharmacokinetic profile and the relative bioavailability of the INL-001 matrix during and after open hernioplasty compared to Marcaine™ 0.25% infiltration.

Conditions

  • Hernioplasty

Interventions

COMBINATION_PRODUCT

INL-001 (bupivacaine HCl collagen implant)

3 x 100 mg INL-001 bupivacaine HCl collagen-matrix implants (total bupivacaine HCl dose 300 mg)

DRUG

Marcaine 0.25% infiltration

Marcaine 0.25% (bupivacaine HCl) 175 mg infiltration

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • Innocoll

    lead INDUSTRY

Principal Investigators

  • Gwendolyn Niebler, D.O. · Innocoll

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-02
Primary Completion
2017-08-15
Completion
2017-08-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03234374 on ClinicalTrials.gov