Pharmacokinetic Study of Synera in Healthy Volunteers

ZARS Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Synera

Study type: Interventional

Funder types: Industry

Identifiers

NCT01602757

SC-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Synera

Experimental group

Description:

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.

Treatment:

Drug: Synera