Comparison of Steady-State Pharmacokinetics of Donepezil Transdermal Delivery System with Oral Donepezil.

ABSTRACT:

Background

Donepezil is approved for treatment of dementia of the Alzheimer type and is currently available only in tablet forms in the United States.

Objective

To compare steady-state pharmacokinetics of once-weekly 10-mg/d and 5-mg/d Corplex™ donepezil transdermal delivery systems (TDS) with once-daily 10-mg oral donepezil.

Methods

Open-label, randomized, crossover study (NCT04617782) enrolled healthy participants aged 18-55 years. All participants received 5-mg/d donepezil TDS during the 5-week Period 1, followed by 10-mg/d TDS or 10-mg/d oral donepezil in the 5-week Period 2; treatments were switched in Period 3. Bioequivalence was assessed at steady state on Week 5.

Results

All 60 enrolled participants received 5-mg/d TDS, 55 received 10-mg/d TDS, and 56 r

SUBMITTER: Tariot PN 

PROVIDER: S-EPMC9661317 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature