Pharmacokinetic Study of 5 and 10 mg Corplex™ Donepezil TDS Compared to 10 mg Aricept® in Healthy Volunteers

Phase 1 Completed 60 enrolled Corium, Inc.

RandomizedCrossoverOpen-labelOther

Summary

Phase 1, open-label, randomized, 3-period, 3-treatment, crossover pharmacokinetic study to evaluate the steady-state pharmacokinetics of 5 mg/day and 10 mg/day Corplex™ Donepezil TDS manufactured with the commercial process compared to 10 mg Aricept® in healthy volunteers.

Timeline

Start: 2020-12-08
Primary completion: 2021-04-05
Completion: 2021-04-05

Publications

Tariot PN, Braeckman R, Oh C. Comparison of Steady-State Pharmacokinetics of Donepezil Transdermal Delivery System with Oral Donepezil. J Alzheimers Dis. 2022;90(1):161-172. doi: 10.3233/JAD-220530.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Donepezil	Small molecule	5 mg	Other
Comparator	Donepezil	Small molecule	10 mg	Other

Indications

No indication recorded.