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

NCT04149938 | Completed Phase 1 FDA Drug

• 1 other identifier: SCI-LIDO-PK-002A
• Study Type: interventional
• Target: 54
• 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 (4)

• 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

Study Arms (2)

Lidocaine Patch (Sequence AB)

EXPERIMENTAL

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%; Drug: Lidocaine patch 5%

Lidocaine Patch (Sequence BA)

EXPERIMENTAL

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%; Drug: Lidocaine patch 5%

Interventions

Lidocaine topical system 1.8% DRUG

Also known as: Lidocaine patch 1.8%, ZTlido

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

Lidocaine patch 5% DRUG

Also known as: Lidoderm

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 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

You may not qualify if:

• 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

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; Lidoderm

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

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 31, 2019
• First Posted: November 4, 2019
• Study Start: September 28, 2016
• Primary Completion: October 27, 2016
• Study Completion: October 27, 2016
• Last Updated: November 4, 2019

Record last verified: 2019-11