Pharmacokinetic Comparisons of Two Donepezil Formulations

Summary

To compare the relative bioavailability and pharmacokinetic characteristics of a newly developed donepezil formulation with a conventional formulation in healthy subjects with a single dose, randomized, open-label, 2-sequence -2period crossover study.

Timeline

Start

2008-01

Primary completion

2008-03

Completion

2008-05

Outcome

Met primary endpoint

paper This study found that the test and reference formulations met the regulatory criteria for pharmacokinetic equivalence in these fasting healthy Korean male subjects. PMID 21723605 ↗

Publications

• Kim KA, Lim JL, Kim C, Park JY. Pharmacokinetic comparison of orally disintegrating and conventional donepezil formulations in healthy Korean male subjects: a single-dose, randomized, open-label, 2-sequence, 2-period crossover study. Clin Ther. 2011 Jul;33(7):965-72. doi: 10.1016/j.clinthera.2011.06.003. Epub 2011 Jul 2.

Drugs

Indications