Phase 1, Randomized Comparative Pharmacokinetic Study of Lidocaine Patch 1.8% (ZTlido™) and Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- Lidocaine topical system 1.8%
- Conditions
- Healthy
- Sponsor
- Scilex Pharmaceuticals, Inc.
- Enrollment
- 54
- Primary Endpoint
- Peak plasma concentration (Cmax) of lidocaine
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Lidocaine Patch (Sequence AB)
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.
Intervention: Lidocaine topical system 1.8%
Lidocaine Patch (Sequence AB)
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.
Intervention: Lidocaine patch 5%
Lidocaine Patch (Sequence BA)
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.
Intervention: Lidocaine topical system 1.8%
Lidocaine Patch (Sequence BA)
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.
Intervention: Lidocaine patch 5%
Outcomes
Primary Outcomes
Peak plasma concentration (Cmax) of lidocaine
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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