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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Lidocaine topical system 1.8%; Drug: Lidocaine patch 5%

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lidocaine Patch (Sequence AB); Subjects received all study treatments: ZTlido and Lidoderm. On Day 1 (Period 1), three ZTlido lidocaine topical systems were applied to the skin on the back for 12 hours. On Day 8 (Period 2), three Lidoderm lidocaine patches were applied to the skin on the back for 12 hours.	Drug: Lidocaine topical system 1.8%; Other Names: ZTlido; Lidocaine patch 1.8%; Drug: Lidocaine patch 5%; Other Names: Lidoderm
EXPERIMENTAL: Lidocaine Patch (Sequence BA); Subjects received all study treatments: ZTlido and Lidoderm. On Day 1 (Period 1), three Lidoderm lidocaine patches were applied to the skin on the back for 12 hours. On Day 8 (Period 2), three ZTlido lidocaine topical systems were applied to the skin on the back for 12 hours.	Drug: Lidocaine topical system 1.8%; Other Names: ZTlido; Lidocaine patch 1.8%; Drug: Lidocaine patch 5%; Other Names: Lidoderm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak plasma concentration (Cmax) of lidocaine	Peak plasma concentration of lidocaine after application of 3 patches for 12 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 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	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	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	0 to 12 hours

Collaborators and Investigators

• Sponsor: Scilex Pharmaceuticals, Inc.

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 28, 2016
• Primary Completion (ACTUAL): October 27, 2016
• Study Completion (ACTUAL): October 27, 2016

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: November 1, 2019
• First Posted (ACTUAL): November 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 4, 2019
• Last Update Submitted That Met QC Criteria: November 1, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: SCI-LIDO-PK-002A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No