Comparative Pharmacokinetic Study of Lidocaine Patch 1.8% (ZTlido™) and Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects

Phase 1, Randomized Comparative Pharmacokinetic Study of Lidocaine Patch 1.8% (ZTlido™) 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).

Key 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

Key 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