PK and DPK of Lidocaine Dermal Products

Exclusion Criteria

• •1. Women who are pregnant, lactating, breast feeding or have a positive serum pregnancy test at enrollment or positive urine pregnancy test on the morning of each study session.
• •2. Smokers (current use or use over the previous 2 months of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, snuff, gum, patches or electronic cigarettes).
• •3. Participation in any ongoing investigational drug trial/study or clinical drug trial/study.
• •4. History of chronic obstructive pulmonary disease or cor pulmonale, or substantially decreased respiratory reserve, hypoxia, hypercapnia or pre-existing respiratory depression.
• •5. Active positive Hepatitis B, C and/or HIV serologies (see Appendix B).
• •6. Known anemia.
• •7. Positive urine drug screening test.
• •8. Use of chronic prescription medication during the period 0 to 30 days; or over-the counter medication (e.g. antihistamines or topical corticosteroids) and short term (\<30 days) prescription medications during the period 0 to 3 days before a study session (vitamin, herbal supplements and birth control medications not included).
• •9. Donation or loss of greater than one pint of blood within 60 days of entry to the study.
• •10. Any prior adverse reaction to lidocaine. Hypersensitivity to lidocaine, known history of hypersensitivity to local anesthetics of the amide type, other excipients in the patches tested or to adhesives on tapes used to cover or tape strip treatment sites.
• •11. Received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month before enrollment in this study or expects to receive an experimental agent during the study.
• •12. Any condition that would, in the opinion of the Medically Accountable Investigator (MAI), place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
• •13. Consumption of alcohol within 24 h prior to dose administration.
• •14. History as either reported by the subject or evident to the investigator of infectious disease or skin infection or of chronic skin disease (e.g., diabetes, psoriasis, atopic dermatitis).
• •15. Hereditary skin disorders or any skin inflammatory conditions as reported by the research participant or evident to the MAI.
• •16. History of significant dermatologic cancers (e.g., melanoma, squamous cell carcinoma) except basal cell carcinomas that were superficial and did not involve the investigative sites.
• •17. Subject has an obvious difference in skin color between arms or the presence of a skin condition, excessive hair at application site (volar forearms/upper arms), sunburn, raised moles and scars, open sores at application site (volar forearms/upper arms), scar tissue, tattoo or coloration that would interfere with placement of formulations, skin assessment or reactions to lidocaine.
• •18. BMI ≥30 kg/m2.