Pharmacokinetic Study of Synera in Healthy Volunteers

Study Overview
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Brief Summary
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This study will measure the amount of lidocaine and tetracaine in the blood after 2-, 4-, and 12-hour application of 4 Synera patches and a 4 hour application of 4 patches without heat.

Detailed Description
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The purpose of this study was to evaluate the pharmacokinetic profiles of lidocaine and tetracaine after 2-, 4-, and 12-hour application of 4 Synera® patches and a 4-hour application of 4 lidocaine/tetracaine patches without heat in healthy adult subjects and to monitor the frequency and nature of adverse events. In addition to determining the pharmacokinetics for a one-time application of 4 Synera® patches, steady-state pharmacokinetics were modeled and residual patch concentrations of lidocaine and tetracaine were determined.

Official Title
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An Open-Label Pharmacokinetic Study of the Synera Patch Applied for 2-, 4-, and 12-hours and a Lidocaine/Tetracaine Patch Without Heat Applied for 4 Hours in Healthy Adult Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Synera


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be at least 18 years of age be a nonsmoker have a body mass index (BMI) ≥ 18.5 and < 30.0 Exclusion Criteria: known or suspected hypersensitivity, allergies, or other contraindications to any compound present in the study drug, including lidocaine, tetracaine, or other local anesthetics. have a defect, injury or a dermatological disease or condition in the skin area where the study drug was to be applied. have a history or current evidence of any hepatic impairment. have failed the urine drug screen. have used or been administered a local or systemic anesthetic, including over-the-counter products, within the past 14 days. have donated blood or plasma within the past 30 days. have participated in a clinical research study within the past 30 days. are pregnant, breastfeeding, or was a female of childbearing potential and not practicing adequate birth control

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Synera<br>Subjects received 4 Synera® patches for 2 hours in Session 1 and 4 patches for 12 hours in Session 4. During Study Session 2, subjects were randomly assigned to 4-hour applications of either 4 Synera® patches or 4 lidocaine/tetracaine patches without heat (no heat patches) and were crossed over during Study Session 3. | Drug: Synera<br>* Subjects received 4 Synera® patches for 2 hours in Session 1 and 4 patches for 12 hours in Session 4. During Study Session 2, subjects were randomly assigned to 4-hour applications of either 4 Synera® patches or 4 lidocaine/tetracaine patches without heat (no heat patches) and were crossed over during Study Session 3.<br>* Other names: Lidocaine 70 mg/Tetracaine 70 mg topical patch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak plasma concentration (Cmax) of Synera after application of 4 patches | Peak plasma concentration of Synera after application of 4 patches for 2-, 4- and 12-hours | 0.5, 1, 1.5, 2, 4, 8, 10, 12 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | 24 days | 
| Area under the plasma concentration versus time (AUC) of Synera | Area under the plasma concentration versus time curve of Synera after application of 4 patches for 2-, 4-, and 12 hours | 0.5, 1, 1.5, 2, 4, 8, 10, 12 hours post-dose |