Healthy
Conditions
Brief summary
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%
Interventions
One topical system is applied to the subject's back for 12 hours.
One generic lidocaine patch is applied to the subject's back for 12 hours.
Sponsors
Scilex Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Adhesion | 12 hours post-dose | 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. |
Countries
United States
Outcome results
None listed