Pharmacokinetic Study of Synera in Healthy Volunteers

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ZARS Pharma Inc.
• Treatments: Lidocaine; Tetracaine

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