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Pharmacokinetics of Lidocaine in Healthy Adults

NCT03310970 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2021-11-01

Study results available
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Summary

The study to be performed will utilize already FDA-approved marketed products in healthy adults for the purpose to generate data for establishing rate of drug delivery of Lidoderm® topical patch (manufactured by Endo Pharmaceuticals) and the lidocaine 5% patch (manufactured by Mylan Pharmaceuticals) in healthy adults, and to ensure the safety of individuals utilizing these types of products.

Conditions

  • Healthy

Interventions

DRUG

Lidocaine 5% patch

Each subject will wear three generic Lidocaine 5% topical patches for 12 hours.

DRUG

Lidocaine hydrochloride

Each subject will receive a dose of 0.5 mg/kg intravenously over a period of 5 minutes.

DRUG

Lidoderm 5% patch

Each subject will wear three Lidoderm® topical patches for 12 hours.

Sponsors & Collaborators

  • Long Island University

    collaborator OTHER

  • Nicole K Brogden

    lead OTHER

Principal Investigators

  • Nicole K Brogden, PharmD, PhD · University of Iowa

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-03-14
Primary Completion
2019-10-09
Completion
2019-10-09
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 NCT03310970 on ClinicalTrials.gov