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

• Status: Completed
• Trial end date: 2016-10-27
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Scilex Pharmaceuticals, Inc.
• Treatments: Lidocaine

Criteria

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