ASAN Medical Center
Seoul, 138-736, South Korea
NCT Number: NCT02178124
Study of the Safety, tolerability and pharmacokinetics with multiple doses of donepezil patch in healthy male subjects
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Notify Me20 year–45 year
Male
Interventional
Phase 1
Seoul, 138-736, South Korea
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: patch : -1d~33d, oral : -1~11d
evaluation item
Time frame: patch: -1~25d, oral -1~11d
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
Icure Pharmaceutical Inc.
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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