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CompletedNCT04144192Updated May 23, 2024

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

A Phase 1 interventional study of Lidocaine patch 1.8% and Lidocaine 5% patch in Healthy, sponsored by Scilex Pharmaceuticals, Inc.. Completed. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-23.

Sponsored by Scilex Pharmaceuticals, Inc. · Phase 1, Interventional, and Other

From the registry’s dates

  • Primary completion was Jul 2014, 12 years 2 months ago, and no results have been posted to the registry.
  • Registered 5 years 6 months after the study started (first participant enrolled Apr 2014, registered Oct 2019).
Phase
Phase 1
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Scilex Pharmaceuticals, Inc. is the lead sponsor of 13 studies on the registry; none are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
58 participants (actual)

Study arms

  • 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 patch 1.8% · Drug: Lidocaine 5% patch · Drug: Lidocaine 2% Injectable Solution

  • 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 patch 1.8% · Drug: Lidocaine 5% patch · Drug: Lidocaine 2% Injectable Solution

Interventions

  • DrugLidocaine patch 1.8%

    Also known as: Lidocaine topical system 1.8%

  • DrugLidocaine 5% patch

    Also known as: Lidoderm

  • DrugLidocaine 2% Injectable Solution
06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 32606914 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04144192
Lead sponsor
Scilex Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Oct 30, 2019
Start date
Apr 28, 2014
Primary completion
Jul 24, 2014
Completion
Jul 24, 2014
Last update
May 23, 2024

Study contacts

Phillip LaStella, MD
principal investigator · TKL Research, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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