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Pharmacokinetic Study of Synera in Healthy Volunteers

NCT ID: NCT01602757

Last Updated: 2012-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Synera

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Lidocaine 70 mg/Tetracaine 70 mg topical patch

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ZARS Pharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anthony R Godfrey, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

Cetero Research, San Antonio

Locations

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Cetero Research

Fargo, North Dakota, United States

Site Status

Countries

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United States

References

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Marriott TB, Charney MR, Stanworth S. Effects of application durations and heat on the pharmacokinetic properties of drug delivered by a lidocaine/tetracaine patch: a randomized, open-label, controlled study in healthy volunteers. Clin Ther. 2012 Oct;34(10):2174-83. doi: 10.1016/j.clinthera.2012.08.008. Epub 2012 Sep 1.

Reference Type RESULT
PMID: 22943969 (View on PubMed)

Other Identifiers

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SC-101

Identifier Type: -

Identifier Source: org_study_id