CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 23 enrolled
Drug / intervention
Lidocaine 5% patch +2 moredrug
Likely dose
Lidocaine hydrochloride 0.5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03310970
NCT03310970Phase 4Completed
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Absolute Bioavailability/Pharmacokinetic and Residual Drug Analysis of Topical Lidocaine in Healthy Adults

Nicole K Brogden·interventional·Posted Oct 16, 2017·Updated Nov 1, 2021

In Brief

A Phase 4 clinical trial evaluating Lidocaine 5% patch, Lidocaine hydrochloride, and 1 other intervention for Healthy. Completed, enrolled 23 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
CollaboratorsLong Island University

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedOct 16, 2017
Enrollment StartMar 14, 2018
Primary CompletionOct 9, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 8.7 years ago

Interventions

Lidocaine 5% patchdrug

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

Lidocaine hydrochloridedrug

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

Lidoderm 5% patchdrug

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