The purpose of this study is to assess the adhesion of BTDS patch 40 µg/h.
The objective is to show non-inferiority in adhesion of BTDS patch 40 µg/h compared to BTDS patch 20 µg/h. Safety and tolerability of both patches will also be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
40
BioKinetic Europe Ltd
Belfast, United Kingdom
Patch Adhesion score
Time frame: 7 days
Observer Rating Scale of Patch prior to Removal questionnaire
does the patch shift, buckle, curl, fall off, change colour or smell
Time frame: 7 days
Skin reaction assessment score
Time frame: day 8
Adverse Events
Time frame: Up to 7-10 days post patch removal
Changes in haematology and biochemistry values
Time frame: Up to 7-10 days after last patch removal
Vital signs
Time frame: Up to 7-10 days after last patch removal
ECG
Time frame: Up to 7-10 days after last patch removal
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