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

NCT04144192 — Phase 1, Completed, 58 participants, Scilex Pharmaceuticals, Inc.
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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

RegistryNCT04144192
StatusCompleted
PhasePhase 1
Study typeInterventional; randomized, crossover, masking: none, other
Enrollment58 (Actual)
SponsorScilex Pharmaceuticals, Inc. (Industry)
ConditionsHealthy
InterventionsLidocaine patch 1.8%, Lidocaine 5% patch, Lidocaine 2% Injectable Solution (Drug)
Datesstart 2014-04-28, primary completion 2014-07-24, completion 2014-07-24, first posted 2019-10-30, last updated 2024-05-23

Related Papers Related Patents Related Grants Related Experts
All trials for Healthy All trials of Lidocaine patch 1.8% All trials of Lidocaine 5% patch

-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).

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+Arms and interventions

ArmTypeInterventionsDescription
Lidocaine Patch (Sequence AB)ExperimentalDrug: Lidocaine patch 1.8%; Drug: Lidocaine 5% patch; Drug: Lidocaine 2% Injectable SolutionSubjects 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.
Lidocaine Patch (Sequence BA)ExperimentalDrug: Lidocaine patch 1.8%; Drug: Lidocaine 5% patch; Drug: Lidocaine 2% Injectable SolutionSubjects 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.
  • Lidocaine patch 1.8% (Drug), also known as Lidocaine topical system 1.8%
  • Lidocaine 5% patch (Drug), also known as Lidoderm
  • Lidocaine 2% Injectable Solution (Drug)

+Outcome measures

Primary outcomes

  • Peak plasma concentration (Cmax) of lidocaine [0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose]: Peak plasma concentration of lidocaine after application of 3 patches for 12 hours
  • Area under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time 48 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 versus time curve from 0 to 48 hours of lidocaine in plasma
  • Area under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time Infinity [0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose]: Area under the plasma concentration versus time curve from 0 to infinite time of lidocaine in plasma

+Eligibility

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

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:

* 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

+Publications

  • Results publication: 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

+Investigators