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Pharmacokinetic Study of Synera in Healthy Volunteers

Information source: ZARS Pharma Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Synera (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: ZARS Pharma Inc.

Official(s) and/or principal investigator(s):
Anthony R Godfrey, Pharm.D., Principal Investigator, Affiliation: Cetero Research, San Antonio

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.

Clinical Details

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 design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: Peak plasma concentration (Cmax) of Synera after application of 4 patches

Secondary outcome:

Number of participants with adverse events

Area under the plasma concentration versus time (AUC) of Synera

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Cetero Research, Fargo, North Dakota 58104, United States
Additional Information

Starting date: February 2010
Last updated: October 15, 2012

Page last updated: August 23, 2015

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