Safety and Efficacy Study of an Iontophoretic Patch Containing Lidocaine and Epinephrine for Venipuncture in Healthy Adult Volunteers

Inclusion criteria

• Subjects may be of any race, either sex, and must be >18 years of age
• Healthy subjects as per medical screening
• Subjects must have intact, healthy skin (no tattoos, surgical scars, skin infections, etc.) where the iontophoresis treatment will be performed
• Subjects must be alert, oriented, mentally competent, and able to understand and comply with the requirements of the study
• Subjects must have signed and dated a written informed consent
• Female subjects of childbearing potential must have a negative pregnancy test result prior to the iontophoresis treatment

Exclusion criteria

• Subjects with a known allergy or sensitivity to lidocaine, epinephrine or other local anesthetics of the amide or ester type
• Subjects with a know sensitivity to any components (e.g. adhesives) of the IDDSSubjects who have undergone venipuncture in the treatment area within the prior 2 weeks or longer if bruising or hematoma is apparent
• Subjects who have taken an analgesic pain medication during the 24-hour period prior to the venipuncture in the posterior surface of the hand
• Subjects with skin allergies or have skin diseases (e.g. psoriasis, eczema
• Subjects with an open skin lesion at the treatment site
• Subjects who are pregnant or breastfeeding
• Subjects exposed to an investigational drug or device within the past 30 days or are involved concurrently in other treatment clinical trials
• Subjects who participated in previous DTI/Transcu clinical studies related to this product
• Subjects with known concurrent illness
• Subjects with "current" known/admitted substance abuse (alcohol/drug)
• Subjects with pacemakers and/or externally mounted electronic devices
• Current or history of conditions that contraindicate use of iontophoretic treatment or venipuncture