Pharmacokinetic Study of Synera in Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01602757

Run by

ZARS Pharma Inc.

People needed

12

Starts

2010-02-01

Expected to finish

2010-03-01

Last updated by the study team

2012-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• be at least 18 years of age
• be a nonsmoker
• have a body mass index (BMI) ≥ 18.5 and < 30.0

You may not qualify if…

• 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

Where it is running

• Cetero Research — Fargo, North Dakota, United States

Full record on ClinicalTrials.gov

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