This is a single-center, 4-group, open-label study in Japanese healthy elderly males. A total of 48 subjects will be randomized to one of four groups (A to D, 12 subjects/group) to administer one E2022 tape to designated sites.
This study consists of Screening, Treatment Period, and Follow-up. The Treatment Period is subdivided into three periods (Periods 1 to 3). Screening will start within 4 weeks before starting Treatment Period 1. In Treatment Periods 1 and 2, one E2022 tape will be applied to the designated site. The Treatment Period 2 application must have at least a 17-day interval from the end of Treatment Period 1 application. In Treatment Period 3, E2022 tape will be applied to back site (contralateral to the first applied site during Treatment Periods 1 and 2) after at least 17 days from the end of Treatment Period 2 (removing). A new E2022 tape will be applied to the same site after the specified intervals from the end of previous application (removing) in each group. Follow-up will start after at least a 17-day interval from the end of re-application in the Treatment Period 3 (removing).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
transdermal E2022 tape formulation (8.1 cm x 8.1 cm)
Unnamed facility
Kagoshima, Kagoshima-ken, Japan
Number and frequency of adverse events
Time frame: 168 hours after the end of application
Pharmacokinetics of E2022: Cmax
Maximal Drug Concentration (Cmax)
Time frame: 216 hours after the end of application
Pharmacokinetics of E2022: AUC
Area Under the Plasma Concentration-Time Curve (AUC)
Time frame: 216 hours after the end of application
Pharmacokinetics of E2022: Tmax
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 216 hours after the end of application
Pharmacokinetics of E2022: t1/2
Plasma Decay Half-Life (t1/2)
Time frame: 216 hours after the end of application
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