A double-blind, randomized, 2-period, placebo-controlled, single-center, crossover study to assess the therapeutic equivalence of the EMLA current reference patch and the EMLA test patch in healthy subjects.
EMLA test patch, EMLA current reference patch, Placebo Patch
18 Years - 60 Years
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Supportive Care
Verified 01 Jul 2018 by AstraZeneca
PAREXEL International GmbH
No locations available
|Active Comparator: Cohort 1|
EMLA Test Patch.
Drug: EMLA test patch
EMLA® Test Patch containing the active ingredients lidocaine base 25 mg/g and prilocaine base 25 mg/g in an oil-in-water emulsion saturating the absorbent cellulose disc. The source of cellulose for the cellulose disc will be provided from a new supplier in this test patch.
|Active Comparator: Cohort 2|
EMLA Reference Patch.
Drug: EMLA current reference patch
EMLA current Reference Patch, containing the active ingredients lidocaine base 25 mg/g and prilocaine base 25 mg/g in an oil-in-water emulsion saturating the absorbent cellulose disc.
|Placebo Comparator: Cohort 3|
Drug: Placebo Patch
Placebo Patch, based on the EMLA Test Patch (incorporating the absorbent cellulose disc with cellulose from the current supplier), where the absorbent disc will be saturated with a placebo oil-in-water emulsion, where the eutectic mixture of lidocaine and prilocaine is replaced with fractionated coconut oil and chlorhexidine digluconate 20%, with identical appearance to the active EMLA patches.