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Completed

NCT Number: NCT01602757

Pharmacokinetic Study of Synera in Healthy 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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cetero Research

Fargo, North Dakota, 58104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Synera

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of participants with adverse events

    Time frame: 24 days

  2. 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

Sponsors and collaborators

Lead sponsor

ZARS Pharma Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 21, 2012
Registry last updated
Oct 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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