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Adhesion Performance Study of Lidocaine Topical System 1.8% Compared to Generic Lidocaine Patch 5% in Healthy, Adult, Human Subjects

NCT04319926 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-04-24

No results posted yet for this study

Summary

An open label, randomized, two-treatment, two-period, single-dose study evaluating the product adhesion in healthy, adult subjects using ZTlido 1.8% Topical System and a generic Lidocaine Patch 5%

Conditions

  • Healthy

Interventions

DRUG

lidocaine topical system 1.8%

One topical system is applied to the subject's back for 12 hours.

DRUG

lidocaine patch 5%

One generic lidocaine patch is applied to the subject's back for 12 hours.

Sponsors & Collaborators

  • Scilex Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Patrick Luger, MD · AXIS Clinicals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-07
Primary Completion
2018-09-09
Completion
2018-09-09
FDA Drug
Yes

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 NCT04319926 on ClinicalTrials.gov