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

Scilex Pharmaceuticals, Inc.54 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Lidocaine topical system 1.8%DRUG

Lidocaine patch 5%DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Peak plasma concentration (Cmax) of lidocaine

Peak plasma concentration of lidocaine after application of 3 patches for 12 hours

Time frame: 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose

Area under the Plasma-Concentration Time Curve (AUC) from Time 0 to Time 48 hours

Area under the plasma concentration versus time curve from 0 to 48 hours of lidocaine in plasma

Time frame: 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose

Area under the Plasma-Concentration Time Curve (AUC) from Time 0 to Time Infinity

Area under the plasma concentration versus time curve from 0 to infinite time of lidocaine in plamsa

Time frame: 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose

Apparent dose

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

Time frame: 0 to 12 hours

Data from ClinicalTrials.gov

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