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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
History of Changes
  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:

U.S. FDA Resources

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
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:
Tetracaine
Lidocaine
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

ClinicalTrials.gov processed this record on October 17, 2012