A Study to Assess Therapeutic Equivalence Between Test EMLA Patch With Marketed EMLA Patch in Healthy Subjects.

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

October 30, 2017

Primary Completion Date

November 9, 2017

Study Completion Date

November 9, 2017

Conditions
Pain
Interventions
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.

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.

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.

Trial Locations (1)

14050

Research Site, Berlin

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Parexel

INDUSTRY

lead

AstraZeneca

INDUSTRY