Pharmacokinetic Study of Synera in Healthy Volunteers

October 15, 2012 updated by: ZARS Pharma Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Cetero Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Synera
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
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.
Other Names:
  • Lidocaine 70 mg/Tetracaine 70 mg topical patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak plasma concentration (Cmax) of Synera after application of 4 patches
Time Frame: 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
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
Time Frame: 24 days
24 days
Area under the plasma concentration versus time (AUC) of Synera
Time Frame: 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
0.5, 1, 1.5, 2, 4, 8, 10, 12 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZARS Pharma Inc.

Investigators

  • Principal Investigator: Anthony R Godfrey, Pharm.D., Cetero Research, San Antonio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

May 15, 2012

First Submitted That Met QC Criteria

May 17, 2012

First Posted (Estimate)

May 21, 2012

Study Record Updates

Last Update Posted (Estimate)

October 17, 2012

Last Update Submitted That Met QC Criteria

October 15, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SC-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Synera

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe