NCT04319926

Adhesion Performance Study of Lidocaine Topical System 1.8% Compared to Generic Lidocaine Patch 5% in Healthy, Adult, Human Subjects

An Open Label, Randomized, Two-treatment, Two-period, Single-dose Study Evaluating the Product Adhesion in Healthy, Adult Subjects Using ZTlido 1.8% Topical System and a Generic Lidocaine Patch 5%.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Scilex Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

An open label, randomized, two-treatment, two-period, single-dose study evaluating the product adhesion in healthy, adult subjects using ZTlido 1.8% Topical System and a generic Lidocaine Patch 5%

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	lidocaine topical system 1.8%	One topical system is applied to the subject's back for 12 hours.
DRUG	lidocaine patch 5%	One generic lidocaine patch is applied to the subject's back for 12 hours.

Timeline

• Start date: 2018-09-07
• Primary completion: 2018-09-09
• Completion: 2018-09-09
• First posted: 2020-03-24
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study