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

Phase 1, Randomized Comparative Pharmacokinetic Study of Lidocaine Patch 1.8% (ZTlido™) and Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04149938

Enrollment

Registered

2019-11-04

Start date

2016-09-28

Completion date

2016-10-27

Last updated

2019-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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).

Interventions

DRUGLidocaine topical system 1.8%

DRUGLidocaine patch 5%

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

Key Inclusion Criteria: * Must be healthy based on medical history, laboratory work, and physical exam * Be ≥18 and ≤65 years of age * Females of childbearing potential must not be pregnant and be using an acceptable form of birth control * Must be free of any systemic or dermatologic disorder Key

Exclusion criteria

* Use of prescription medication within 14 days or over-the-counter products within 7 days prior to study medication * Current use of opioids * Known hypersensitivity or allergy to any of the components of the product formulations * Any serious illness in the 4 weeks preceding the beginning of treatment that resulted in missed work or hospitalization

Design outcomes

Primary

Measure	Time frame	Description
Peak plasma concentration (Cmax) of lidocaine	0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose	Peak plasma concentration of lidocaine after application of 3 patches for 12 hours
Area under the Plasma-Concentration Time Curve (AUC) from Time 0 to Time 48 hours	0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose	Area under the plasma concentration versus time curve from 0 to 48 hours of lidocaine in plasma
Area under the Plasma-Concentration Time Curve (AUC) from Time 0 to Time Infinity	0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose	Area under the plasma concentration versus time curve from 0 to infinite time of lidocaine in plamsa
Apparent dose	0 to 12 hours	Apparent dose of delivered lidocaine assessed by calculating the quantity of lidocaine in the patch as manufactured minus the quantity recovered from the used patch after 12 hours of wear and adhesive residue remaining on skin and on the product liner and envelope

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026