The effects of miglitol on the pharmacokinetics of phenytoin in healthy volunteers

Abstract

The interaction between miglitol, an a-glucosidase inhibitor used as an adjunct therapy in diabetes, and phenytoin, an anticonvulsant primarily used in the treatment of epilepsy, was studied over 26 days. Twenty-four healthy male volunteers took part in a placebo controlled, double blind, cross-over study in two phases, to determine the effects of multiple 100mg doses of miglitol on a single 400mg dose of phenytoin sodium. Miglitol or placebo was administered three times daily from Day 1 to Day 5. Phenytoin was administered as a single dose on Day 3 of each phase, after which blood samples were taken at regular intervals. A washout period of 14 days separated the two phases.