Pharmacokinetics 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

Clinical Therapeutics
Hea-Young ChoYong-Bok Lee

Abstract

Rebamipide is a quinolinone-derived gastroprotective agent approved in Korea for the treatment of gastric ulcers, acute gastritis, and exacerbated chronic gastritis. The aims of this study were to evaluate the pharmacokinetics and bioequivalence of a reference (branded) and test (generic) formulation of rebamipide 100-mg tablets in healthy Korean male volunteers for the purposes of generic substitution and to evaluate the relationship between genetic polymorphisms in the ABCB1 gene (exons 21 and 26) and rebamipide pharmacokinetics. This study had a 2-period crossover design, with a 7-day washout between formulations. Healthy Korean male volunteers were randomly assigned to receive a single 100-mg dose of the test or reference formulation, administered with 240 mL of water after a 12-hour overnight fast. Serum concentrations of rebamipide up to 12 hours after administration were determined using a validated HPLC method with fluorescence detection. Vital signs (temperature, blood pressure, and heart rate) were measured before and after dosing in both periods. Adverse events were monitored by clinic staff on the days of study drug administration and were recorded for up to 1 week after the last dose of study medication. Pharmacoki...Continue Reading

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Citations

Dec 6, 2011·Archives of Pharmacal Research·Hee-Doo Yoo, Yong-Bok Lee
Dec 18, 2013·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Dustin L CooperSam Harirforoosh
Sep 21, 2016·Drug Development and Industrial Pharmacy·Xinnuo XiongHui Li
Jun 20, 2020·Biopharmaceutics & Drug Disposition·In-Hwan BaekMin Ji Kim

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