Clinical therapeutics
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Clinical therapeutics · Nov 2009
Randomized Controlled Trial Comparative StudyPharmacokinetics and bioequivalence of two formulations of rebamipide 100-mg tablets: a randomized, single-dose, two-period, two-sequence crossover study in healthy Korean male volunteers.
Rebamipide is a quinolinone-derived gastroprotective agent approved in Korea for the treatment of gastric ulcers, acute gastritis, and exacerbated chronic gastritis. ⋯ The results of this study in healthy Korean male volunteers suggest that the 2 rebamipide 100-mg tablet formulations administered in the fasted state met the regulatory criterion for bioequivalence. There was no evidence that rebamipide pharmacokinetic parameters were influenced by genetic polymorphisms in the ABCB1 gene (exons 21 and 26). ClinicalTrials.gov identifier: .