Trial | NCT04144192  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    58
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).
Study Started
Apr 28
2014
Primary Completion
Jul 24
2014
Study Completion
Jul 24
2014
Last Update
Oct 30
2019

Drug Lidocaine patch 1.8%

  • Other names: Lidocaine topical system 1.8%

Drug Lidocaine 5% patch

  • Other names: Lidoderm

Lidocaine Patch (Sequence AB) Experimental

Subjects received all study treatments: a bolus IV injection of 0.7 mg/kg lidocaine IV in the morning of study Day 1, and then lidocaine patch treatment on Day 8 and Day 15. The sequence in which they received patch treatment was determined by random assignment. For subjects in Arm 1, 3 lidocaine 1.8% patches were applied on Day 8 and 3 Lidoderm® 5% patches were applied on Day 15.

Lidocaine Patch (Sequence BA) Experimental

Subjects received all study treatments: a bolus IV injection of 0.7 mg/kg lidocaine IV in the morning of study Day 1, and then lidocaine patch treatment on Day 8 and Day 15. The sequence in which they received patch treatment was determined by random assignment. For subjects in Arm 2, 3 Lidoderm® 5% patches were applied on Day 8 and 3 lidocaine 1.8% patches were applied on Day 15.

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
No Results Posted