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Comparative Pharmacokinetic Study of Lidocaine Patch 1.8% (ZTlido™) and Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects

NCT04149938 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2019-11-04

No results posted yet for this study

Summary

The purpose of this study is to characterize the comparative single-dose pharmacokinetics (bioequivalence) of lidocaine patch 1.8% (investigational product) versus Lidoderm® (lidocaine patch 5%,reference product).

Conditions

  • Healthy

Interventions

DRUG

Lidocaine topical system 1.8%

DRUG

Lidocaine patch 5%

Sponsors & Collaborators

  • Scilex Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Phillip LaStella, MD · TKL Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-28
Primary Completion
2016-10-27
Completion
2016-10-27
FDA Drug
Yes

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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 NCT04149938 on ClinicalTrials.gov