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OpenTrials
Completed

NCT Number: NCT04144192

Pharmacokinetic Study of Lidocaine Patch 1.8% 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).

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine patch 1.8%

Drug

Other names: Lidocaine topical system 1.8%

Lidocaine 5% patch

Drug

Other names: Lidoderm

Lidocaine 2% Injectable Solution

Drug

Primary outcomes

  1. Peak plasma concentration (Cmax) of lidocaine

    Time frame: 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

  2. Area under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time 48 hours

    Time frame: 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

  3. Area under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time Infinity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Scilex Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 30, 2019
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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