A study to assess therapeutic equivalence between test EMLA patch with marketed EMLA patch in healthy subjects. - EMLA

A double-blind, randomized, 2-period, placebo-controlled, single-center, crossover study, efficacy study demonstrating the therapeutic equivalence of the test cellulose disc (matrix) in EMLA patch and the current commercial cellulose disc (matrix) in EMLA patch in healthy subjects.

This study will be a double-blind, randomized, 2-period, placebo-controlled, crossover study in healthy male and female subjects, performed at a single study center. Prior to inclusion, informed consent will be obtained. A brief medical history, including limited demographic data (gender, age and ethnicity) will be recorded, and eligibility for inclusion to the study will be established through a physical inspection of hands. Subjects will be shown how to complete the VAS. Visual analogue scale (VAS) as a research tool is frequently used for the assessment of pain severity and relief. VAS is easy to use and can be applied in a variety of settings; results are reproducible. VAS data are sensitive to treatment effects and can be analyzed using parametric statistical techniques. At each specific study visit, each subject will undergo a left-right comparison of two patch preparations, followed by a repeated test with an alternate combination of preparations. Thus, the study will comprise: Visit 1: EMLA Test Patch plus Placebo Patch OR EMLA Test Patch plus EMLA current Reference Patch. Visit 2: EMLA Test Patch plus EMLA current Reference Patch OR EMLA Test Patch plus Placebo Patch. There will be a washout period of at minimum of 4 calendar days between treatment periods (visits). No follow-up visit is needed. Any adverse event (AE) that is ongoing at the last visit will be followed up as appropriate.