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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-07

Study Completion Date

2018-09-09

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%

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lidocaine Patch (Sequence T1T2)

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.

Group Type EXPERIMENTAL

lidocaine topical system 1.8%

Intervention Type DRUG

One topical system is applied to the subject's back for 12 hours.

lidocaine patch 5%

Intervention Type DRUG

One generic lidocaine patch is applied to the subject's back for 12 hours.

Lidocaine Patch (Sequence T2T1)

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.

Group Type EXPERIMENTAL

lidocaine topical system 1.8%

Intervention Type DRUG

One topical system is applied to the subject's back for 12 hours.

lidocaine patch 5%

Intervention Type DRUG

One generic lidocaine patch is applied to the subject's back for 12 hours.

Interventions

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lidocaine topical system 1.8%

One topical system is applied to the subject's back for 12 hours.

Intervention Type DRUG

lidocaine patch 5%

One generic lidocaine patch is applied to the subject's back for 12 hours.

Intervention Type DRUG

Other Intervention Names

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lidocaine patch 1.8% ZTlido

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes