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Pharmacokinetic Study of Synera in Healthy Volunteers

Sponsor
ZARS Pharma Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01602757
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
28
Duration (Days)
13
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
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
Study Start Date :
Feb 1, 2010
Actual Primary Completion Date :
Mar 1, 2010
Actual Study Completion Date :
Mar 1, 2010

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. Number of participants with adverse events [24 days]

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cetero Research Fargo North Dakota United States 58104

    Sponsors and Collaborators

    • ZARS Pharma Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ZARS Pharma Inc.
    ClinicalTrials.gov Identifier:
    NCT01602757
    Other Study ID Numbers:
    • SC-101
    First Posted:
    May 21, 2012
    Last Update Posted:
    Oct 17, 2012
    Last Verified:
    Oct 1, 2012
    Additional relevant MeSH terms:
    Lidocaine
    Tetracaine

    Study Results

    No Results Posted as of Oct 17, 2012