Healthy
Conditions
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).
Interventions
Sponsors
Scilex Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Must be healthy based on by medical history, laboratory work, and physical exam * Be at least 18 years of age to 65 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
* Use of a prescription medication within 14 days or over-the-counter products within 7 days prior to administration of study medication * Known hypersensitivity or allergy to any of the components of the lidocaine topical system formulation * Any serious illness in the 4 weeks preceding the beginning of treatment that resulted in missed work or hospitalization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 plasma |
Outcome results
None listed