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Completed

NCT Number: NCT04149938

Comparative Pharmacokinetic Study of Lidocaine Patch 1.8% (ZTlido™) and 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.

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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

Treatment and study plan

lidocaine topical system 1.8%

Drug

Other names: Lidocaine patch 1.8%, ZTlido

Lidocaine patch 5%

Drug

Other names: Lidoderm

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 plamsa

  4. Apparent dose

    Time frame: 0 to 12 hours

    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

Sponsors and collaborators

Lead sponsor

Scilex Pharmaceuticals, Inc.

Industry

Registry information

Official study title

Phase 1, Randomized Comparative Pharmacokinetic Study of Lidocaine Patch 1.8% (ZTlido™) and Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 4, 2019
Registry last updated
Nov 4, 2019

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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