Status:
COMPLETED
Adhesion Performance Study of Lidocaine Topical System 1.8% Compared to Generic Lidocaine Patch 5% in Healthy, Adult, Human Subjects
Lead Sponsor:
Scilex Pharmaceuticals, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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%
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
September 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04319926
Start Date
September 7 2018
End Date
September 9 2018
Last Update
April 24 2024
Active Locations (1)
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1
AXIS Clinicals
Dilworth, Minnesota, United States, 56529