Comparative Pharmacokinetic Study of Lidocaine Patch 1.8% (ZTlido™) and Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT04149938
- Lead Sponsor
- Scilex Pharmaceuticals, Inc.
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Lidocaine Patch (Sequence AB) Lidocaine topical system 1.8% 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. Lidocaine Patch (Sequence BA) Lidocaine topical system 1.8% 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. Lidocaine Patch (Sequence AB) Lidocaine patch 5% 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. Lidocaine Patch (Sequence BA) Lidocaine patch 5% 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.
- Primary Outcome Measures
Name Time Method Peak plasma concentration (Cmax) of lidocaine 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose Peak plasma concentration of lidocaine after application of 3 patches for 12 hours
Area under the Plasma-Concentration Time Curve (AUC) from Time 0 to Time Infinity 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose Area under the plasma concentration versus time curve from 0 to infinite time of lidocaine in plamsa
Apparent dose 0 to 12 hours 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
Area under the Plasma-Concentration Time Curve (AUC) from Time 0 to Time 48 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 versus time curve from 0 to 48 hours of lidocaine in plasma
- Secondary Outcome Measures
Name Time Method