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

Phase 1, Randomized, Comparative Pharmacokinetic Study of Bolus Intravenous Lidocaine 0.7 mg/kg, Lidocaine Patch 1.8%, 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 2% Injectable Solution; Drug: Lidocaine patch 1.8%; Drug: Lidocaine 5% patch

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must be healthy based on by medical history, laboratory work, and physical exam
• Be at least 18 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine Patch (Sequence AB); Subjects received all study treatments: a bolus IV injection of 0.7 mg/kg lidocaine IV in the morning of study Day 1, and then lidocaine patch treatment on Day 8 and Day 15. The sequence in which they received patch treatment was determined by random assignment. For subjects in Arm 1, 3 lidocaine 1.8% patches were applied on Day 8 and 3 Lidoderm® 5% patches were applied on Day 15.	Drug: Lidocaine 2% Injectable Solution; Drug: Lidocaine patch 1.8%; Other Names: Lidocaine topical system 1.8%; Drug: Lidocaine 5% patch; Other Names: Lidoderm
Experimental: Lidocaine Patch (Sequence BA); Subjects received all study treatments: a bolus IV injection of 0.7 mg/kg lidocaine IV in the morning of study Day 1, and then lidocaine patch treatment on Day 8 and Day 15. The sequence in which they received patch treatment was determined by random assignment. For subjects in Arm 2, 3 Lidoderm® 5% patches were applied on Day 8 and 3 lidocaine 1.8% patches were applied on Day 15.	Drug: Lidocaine 2% Injectable Solution; Drug: Lidocaine patch 1.8%; Other Names: Lidocaine topical system 1.8%; Drug: Lidocaine 5% patch; 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 plasma	0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose

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): April 28, 2014
• Primary Completion (Actual): July 24, 2014
• Study Completion (Actual): July 24, 2014

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Actual): October 30, 2019
• Last Update Submitted That Met QC Criteria: October 28, 2019
• Last Verified: October 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-001

Drug and device information, study documents

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