Adhesion Performance Study of Lidocaine Topical System 1.8% Compared to Generic Lidocaine Patch 5% in Healthy, Adult, Human Subjects

Study Overview
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Brief Summary
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An open label, randomized, two-treatment, two-period, single-dose study evaluating the product adhesion in healthy, adult subjects using ZTlido 1.8% Topical System and a generic Lidocaine Patch 5%

Official Title
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An Open Label, Randomized, Two-treatment, Two-period, Single-dose Study Evaluating the Product Adhesion in Healthy, Adult Subjects Using ZTlido 1.8% Topical System and a Generic Lidocaine Patch 5%.

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 by medical history, laboratory work, ECG, and physical exam with BMI range between 18.00 and 30.00 kg/m2 inclusive. Be at least 18 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 Key Exclusion Criteria: Allergy or known hypersensitivity to lidocaine, amide-type local anesthetics, or any component of the product formulation Any major medical illness 3 months prior or any significant history or ongoing chronic medical illness Subjects with conditions that might affect application of the product or its adhesive properties (including psoriasis, eczema, atopic dermatitis, damaged or irritated epidermal layer, and excessive hair or oil on the skin) History of addiction, abuse, and misuse of any drug Use of local anesthetics of antiarrhythmic drugs (such as tocainide or mexiletine) within 14 days prior to product application

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine Patch (Sequence T1T2)<br>Subjects receive both lidocaine topical system 1.8% and the generic lidocaine patch 5%. The sequence in which they receive the lidocaine products is determined by random assignment. For subjects in Arm 1, lidocaine 1.8% topical systems are applied in Period 1, and the generic lidocaine 5% patches are applied in Period 2. | Drug: lidocaine topical system 1.8%<br>* One topical system is applied to the subject's back for 12 hours.<br>* Other names: ZTlido;Drug: lidocaine patch 5%<br>* One generic lidocaine patch is applied to the subject's back for 12 hours.<br>|
| Experimental: Lidocaine Patch (Sequence T2T1)<br>Subjects receive both lidocaine topical system 1.8% and the generic lidocaine patch 5%. The sequence in which they receive the lidocaine products is determined by random assignment. For subjects in Arm 2, generic lidocaine 5% patches are applied in Period 1, and the lidocaine 1.8% topical systems are applied in Period 2. | Drug: lidocaine topical system 1.8%<br>* One topical system is applied to the subject's back for 12 hours.<br>* Other names: ZTlido;Drug: lidocaine patch 5%<br>* One generic lidocaine patch is applied to the subject's back for 12 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Adhesion | Percent adhesion is assessed by laying a transparent sheet the exact size of the product over the top of the product and outlining areas of adhesion with a marker on the transparent sheet. The area excluded from the adhered area will be assessed to determine the degree of lift-off. Adhesion is assessed every 3 hours after product application. Mean percent adhesion is calculated as the sum of scores at each assessment time point divided by the total number of observations. | 12 hours post-dose |