Bioequivalence Between Generic and Branded Lamotrigine in People With Epilepsy: The EQUIGEN Randomized Clinical Trial.

ABSTRACT:

Importance

Switching between generic antiepileptic drugs is a highly debated issue that affects both clinical care and overall health care costs.

Objective

To evaluate the single-dose pharmacokinetic bioequivalence of 3 (1 branded and 2 generic drugs) on-market, immediate-release lamotrigine drug products.

Design, setting, and participants

The Equivalence Among Antiepileptic Drug Generic and Brand Products in People With Epilepsy (EQUIGEN) single-dose study is a crossover, prospective, sequence-randomized, replicate pharmacokinetic study conducted at 5 US academic epilepsy centers. Fifty adults (≥18 years) with epilepsy who were taking concomitant antiepileptic drugs and not currently receiving lamotrigine were enrolled between July 18, 2013, and January 19, 2015. Eve

SUBMITTER: Berg M 

PROVIDER: S-EPMC5710324 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature