Status:
COMPLETED
A Study to Assess Therapeutic Equivalence Between Test EMLA Patch With Marketed EMLA Patch in Healthy Subjects.
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Parexel
Conditions:
Pain
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
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 conse...
Eligibility Criteria
Inclusion
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy male and female subjects aged 18 to 60 years.
- Have healthy skin over hands, with no inflammation or open wounds.
- Able to understand, read and speak the German language.
- Easy accessible veins on the dorsum of both hands.
Exclusion
- Current significant active skin disease such as widespread eczema or active atopic dermatitis.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the PI, to local anesthetics of the amide type or to any of the components of the EMLA emulsion (e.g., castor oil polyoxyl hydrogenated).
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the PI to chlorohexidine (preservative in the placebo patch emulsion).
- Subjects who previously entered this study.
- Involvement of any AstraZeneca, PAREXEL or study site employee or their close relatives.
- Judgement by the PI that the subject should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
- Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
Key Trial Info
Start Date :
October 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 9 2017
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03313336
Start Date
October 30 2017
End Date
November 9 2017
Last Update
November 14 2017
Active Locations (1)
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1
Research Site
Berlin, Germany, 14050