Healthy
Conditions
Brief summary
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
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.
Interventions
DRUGSynera
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.
Sponsors
ZARS Pharma Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak plasma concentration (Cmax) of Synera after application of 4 patches | 0.5, 1, 1.5, 2, 4, 8, 10, 12 hours post-dose | Peak plasma concentration of Synera after application of 4 patches for 2-, 4- and 12-hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events | 24 days | — |
| Area under the plasma concentration versus time (AUC) of Synera | 0.5, 1, 1.5, 2, 4, 8, 10, 12 hours post-dose | Area under the plasma concentration versus time curve of Synera after application of 4 patches for 2-, 4-, and 12 hours |
Countries
United States
Outcome results
None listed