Overview

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

Status:
Completed
Trial end date:
2014-07-24
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
Inclusion Criteria:

- Must be healthy based on by medical history, laboratory work, and physical exam

- Be at least 18 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