Pharmacokinetic Study of Synera in Healthy Volunteers
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
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Feb 2010
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 15, 2012
CompletedFirst Posted
Study publicly available on registry
May 21, 2012
CompletedOctober 17, 2012
October 1, 2012
28 days
May 15, 2012
October 15, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (1)
Synera
EXPERIMENTALSubjects 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- be at least 18 years of age
- be a nonsmoker
- have a body mass index (BMI) ≥ 18.5 and \< 30.0
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ZARS Pharma Inc.lead
Study Sites (1)
Cetero Research
Fargo, North Dakota, 58104, United States
Related Publications (1)
Marriott TB, Charney MR, Stanworth S. Effects of application durations and heat on the pharmacokinetic properties of drug delivered by a lidocaine/tetracaine patch: a randomized, open-label, controlled study in healthy volunteers. Clin Ther. 2012 Oct;34(10):2174-83. doi: 10.1016/j.clinthera.2012.08.008. Epub 2012 Sep 1.
PMID: 22943969RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anthony R Godfrey, Pharm.D.
Cetero Research, San Antonio
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2012
First Posted
May 21, 2012
Study Start
February 1, 2010
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
October 17, 2012
Record last verified: 2012-10