Pharmacokinetic Study of Synera in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ZARS Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01602757
First received: May 15, 2012
Last updated: October 15, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Healthy
Drug: Synera
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by ZARS Pharma Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Peak plasma concentration of Synera after application of 4 patches for 2-, 4- and 12-hours


Secondary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 24 days ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
    Area under the plasma concentration versus time curve of Synera after application of 4 patches for 2-, 4-, and 12 hours


Enrollment: 12
Study Start Date: February 2010
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Lidocaine 70 mg/Tetracaine 70 mg topical patch

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01602757

Locations
United States, North Dakota
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
  More Information

Publications:
Responsible Party: ZARS Pharma Inc.
ClinicalTrials.gov Identifier: NCT01602757     History of Changes
Other Study ID Numbers: SC-101
Study First Received: May 15, 2012
Last Updated: October 15, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lidocaine
Tetracaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014