PK and DPK of Lidocaine Dermal Products

Inclusion Criteria

• Men or non-pregnant, women who are of any ethnic background between the age of 18 and 45 years old.
• Subjects must be non-smokers (must have refrained from the use of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, snuff, gum, patches or electronic cigarettes) over the previous 2 months and are not currently using tobacco products.
• Provide written informed consent before initiation of any of the study procedures.
• Agrees not to participate in another clinical trial/study or to participate in an investigational drug study for at least 1 month after the last study session.
• Able to adhere to the study restrictions and protocol schedule.
• Able to participate in all study sessions.
• Has a volar forearm of either at least 24 cm (9.45 inches) in length or of sufficient size that can accommodate the formulations to be tested in a study area that begins at least 5 cm (1.97 inches) above the wrist and ends a minimum of 0.5 cm (0.197 inches) below the antecubital fossa (i.e., the bend in the arm at the elbow).
• Subjects have upper arms (minimum 28 cm (11 inch) circumference) large enough to allow for the placement of two 140 cm2 patches on one upper arm or one 140 cm2 patch on each upper arm.
• Subjects deemed to be healthy as judged by the MAI and determined by medical history, physical examination and medication history.
• Negative urine drug screening test.
• Have normal screening laboratories for WBC, CBC, Hgb, platelets, sodium, potassium, chloride, bicarbonate, BUN, creatinine, ALT and AST.
• Have normal screening laboratories for urine protein and urine glucose.
• Female subjects must be of non-childbearing potential (as defined as surgically sterile [i.e., history of hysterectomy or tubal ligation] or postmenopausal for more than 1 year), or if of childbearing potential must be non-pregnant at the time of enrollment and on the morning of each procedure day, and must agree to use hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner.
• Agrees not to donate blood to a blood bank throughout participation in the study and at least 3 months after the last procedure day.
• Have a normal ECG; must not have the following to be acceptable: pathologic Q wave abnormalities, significant ST-T wave changes, left ventricular hypertrophy, right bundle branch block, left bundle branch block. (sinus rhythm is between 55-100 beats per minute).
• Have normal vital signs:
• Temperature 35-37.9°C (95-100.3°F)
• Systolic blood pressure 90-140 mmHg
• Diastolic blood pressure 60-90 mmHg
• Heart rate 55-100 beats per minute
• Respiration rate 12-20 breaths per minute

Exclusion Criteria

• 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.
• 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).
• Participation in any ongoing investigational drug trial/study or clinical drug trial/study.
• History of chronic obstructive pulmonary disease or cor pulmonale, or substantially decreased respiratory reserve, hypoxia, hypercapnia or pre-existing respiratory depression.
• Active positive Hepatitis B, C and/or HIV serologies (see Appendix B).
• Known anemia.
• Positive urine drug screening test.
• 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).
• Donation or loss of greater than o