Comparative Pharmacokinetic Study of Lidocaine Patch 1.8% (ZTlido™) and Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects

Phase 1 Completed 54 enrolled Scilex Pharmaceuticals, Inc.

RandomizedCrossoverOpen-labelOther

Summary

The purpose of this study is to characterize the comparative single-dose pharmacokinetics (bioequivalence) of lidocaine patch 1.8% (investigational product) versus Lidoderm® (lidocaine patch 5%,reference product).

Timeline

Start: 2016-09-28
Primary completion: 2016-10-27
Completion: 2016-10-27

Publications

Gudin J, Argoff C, Fudin J, Greuber E, Vought K, Patel K, Nalamachu S. A Randomized, Open-Label, Bioequivalence Study of Lidocaine Topical System 1.8% and Lidocaine Patch 5% in Healthy Subjects. J Pain Res. 2020 Jun 22;13:1485-1496. doi: 10.2147/JPR.S237934. eCollection 2020.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lidocaine	Other / unclassified	1.8 %	Topical
Subject	Lidocaine	Other / unclassified	5 %	Topical

Indications

No indication recorded.