Pharmacokinetic Study of Lidocaine Patch 1.8% Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects

Phase 1, Randomized, Comparative Pharmacokinetic Study of Bolus Intravenous Lidocaine 0.7 mg/kg, Lidocaine Patch 1.8%, and Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects

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).

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