Study of the Safety, tolerability and pharmacokinetics with multiple doses of donepezil patch in healthy male subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
24
ASAN Medical Center
Seoul, South Korea
safety and tolerability evaluation
evaluation item 1. adverse event 2. electrocardiographie 3. vital sign 4. physical examination 5. urine, blood test 6. skin irritation
Time frame: patch : -1d~33d, oral : -1~11d
pharmacokinetics characteristic evaluation
cohort 1 1d 0h (pre-dose), 4h, 8h, 12h, 24h (2d), 48h (3d), 72h (4d), 144h (7d), 216h (10d), 288h (13d, last dose start), 292h, 296h, 300h, 312h (14d), 336h (15d), 360h (16d, patch removal), 362h, 364h, 368h, 372h, 384h (17d), 408h (18d), 432h (19d), 480h (21d), 528h (23d), 576h (25d) cohort 2 1 period Oral Donepezil 1d 0h (pre-dose), 0.5h, 1h, 1.5h, 2h, 3h, 4h, 8h, 12h, 24h (2d), 48h (3d), 96h (5d), 144h (7d), 192h (9d), 240h (11d) period 2 Donepezil Patch: same cohort1 evaluation item : donepezil conc. evaluation variable patch : AUCτ,ss, Cmax,ss, t1/2β, AI (accumulation index), Cav,ss oral : AUClast, AUC0-∞, Cmax, tmax, t1/2β, CL/F
Time frame: patch: -1~25d, oral -1~11d
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