Pharmacokinetic Study of Lidocaine Patch 1.8% Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects

Scilex Pharmaceuticals, Inc.58 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 patch 1.8%DRUG

Lidocaine 5% patchDRUG

Lidocaine 2% Injectable SolutionDRUG

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Must be healthy based on by medical history, laboratory work, and physical exam * Be at least 18 years of age to 65 years of age * If childbearing potential, use of acceptable form of birth control * In the case of females of childbearing potential, have a negative serum pregnancy test Exclusion Criteria: * Use of a prescription medication within 14 days or over-the-counter products within 7 days prior to administration of study medication * Known hypersensitivity or allergy to any of the components of the lidocaine topical system formulation * 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 plasma

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

Data from ClinicalTrials.gov

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