A Randomized, Crossover, Adhesion Performance and Pharmacokinetic Study of a Lidocaine Topical System Under Conditions of Water Exposure in Healthy Subjects.

ABSTRACT:

Purpose

This study compares the adhesion performance, pharmacokinetic profile, and safety of lidocaine topical system 1.8%, which is approved to treat postherpetic neuralgia, under conditions of swimming and showering versus normal conditions.

Patients and methods

This open-label, 3-period, 3-treatment crossover study randomized 24 healthy adults to receive one lidocaine topical system during each of three treatment periods; subjects either swam in a heated swimming pool for 15 minutes 4.0 hours post-product application (swimming), showered for 10 minutes 8.0 hours after product application (showering), or the product remained dry throughout the treatment period (normal conditions). The product was applied to the mid-upper back and was removed after 12 hours. The pharmacokin

SUBMITTER: Vought K 

PROVIDER: S-EPMC8379683 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature