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Pharmacokinetics and Adhesion of Lidocaine Topical System 1.8% With Water Exposure

Healthy Clinical Trial

Official title:
A Phase 1, Open Label, Randomized, Three-treatment, Three-sequence, Three-period, Crossover Adhesion Performance and Pharmacokinetic Study of Lidocaine Topical System 1.8% in Healthy, Adult Subjects Under Normal and Two Water Stress Conditions

Clinical Trial Summary

The objectives of this study are to evaluate the adhesion performance and pharmacokinetics of ZTlido (lidocaine topical system) 1.8% during swimming, showering, and under normal conditions.

Clinical Trial Description

In this Phase 1, open-label, three-period crossover study, 24 healthy, adult male and female subjects are randomized to 1 of 3 treatment sequences. During each treatment period, subjects have one lidocaine topical system applied to their back for 12 hours with a 4-day washout between treatments. In each treatment period, the subject will either swim (Treatment A), shower (Treatment B), or refrain from these activities (Treatment C) while wearing the topical system. Blood samples for lidocaine PK will be collected pre-dose until 24 hours. Adhesion will be monitored throughout the wear time and skin irritation will be assessed the topical system is removed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04784728
Study type Interventional
Source Scilex Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 1
Start date August 21, 2019
Completion date August 31, 2019
View Details
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