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

Study Overview
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Brief Summary
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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).

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Lidocaine topical system 1.8%
* Drug: Lidocaine patch 5%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine Patch (Sequence AB)<br>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%<br> <br> * Other names: ZTlido;Drug: Lidocaine patch 5%<br> <br> * Other names: Lidoderm;|
| Experimental: Lidocaine Patch (Sequence BA)<br>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%<br> <br> * Other names: ZTlido;Drug: Lidocaine patch 5%<br> <br> * Other names: Lidoderm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |