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

NCT04144192 | Completed Phase 1 FDA Drug

• 1 other identifier: SCI-LIDO-PK-001
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Lidocaine Patch (Sequence AB)

EXPERIMENTAL

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 patch 1.8%; Drug: Lidocaine 5% patch; Drug: Lidocaine 2% Injectable Solution

Lidocaine Patch (Sequence BA)

EXPERIMENTAL

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 patch 1.8%; Drug: Lidocaine 5% patch; Drug: Lidocaine 2% Injectable Solution

Interventions

Lidocaine patch 1.8% DRUG

Also known as: Lidocaine topical system 1.8%

Lidocaine Patch (Sequence AB); Lidocaine Patch (Sequence BA)

Lidocaine 5% patch DRUG

Also known as: Lidoderm

Lidocaine Patch (Sequence AB); Lidocaine Patch (Sequence BA)

Lidocaine 2% Injectable Solution DRUG

Lidocaine Patch (Sequence AB); Lidocaine Patch (Sequence BA)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scilex Pharmaceuticals, Inc.: lead

Related Publications (1)

• 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.

  PMID: 32606914 DERIVED

MeSH Terms

Interventions

Lidocaine; Transdermal Patch; Lidoderm

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Equipment and Supplies

Study Officials

• Phillip LaStella, MD

  TKL Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 30, 2019
• Study Start: April 28, 2014
• Primary Completion: July 24, 2014
• Study Completion: July 24, 2014
• Last Updated: May 23, 2024

Record last verified: 2024-05