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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Lidocaine patch 1.8%
* Drug: Lidocaine 5% patch
* Drug: Lidocaine 2% Injectable Solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine Patch (Sequence AB)<br>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. | Drug: Lidocaine patch 1.8%<br> <br> * Other names: Lidocaine topical system 1.8%;Drug: Lidocaine 5% patch<br> <br> * Other names: Lidoderm;Drug: Lidocaine 2% Injectable Solution<br> <br> |
| Experimental: Lidocaine Patch (Sequence BA)<br>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. | Drug: Lidocaine patch 1.8%<br> <br> * Other names: Lidocaine topical system 1.8%;Drug: Lidocaine 5% patch<br> <br> * Other names: Lidoderm;Drug: Lidocaine 2% Injectable Solution<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak plasma concentration (Cmax) of lidocaine | Peak plasma concentration of lidocaine after application of 3 patches for 12 hours | 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose | 
| Area under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time 48 hours | Area under the plasma concentration versus time curve from 0 to 48 hours of lidocaine in plasma | 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose | 
| Area under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time Infinity | Area under the plasma concentration versus time curve from 0 to infinite time of lidocaine in plasma | 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose |