ArticleNaunyn-Schmiedeberg's archives of pharmacology2025
Population modeling of pharmacokinetic variability of epinastine, a histamine H
Article in Naunyn-Schmiedeberg's archives of pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Although epinastine has been actively used in clinical practice for treatment of allergic diseases, attempts to interpret and quantify pharmacokinetic (PK) diversity within population have been very limited. In particular, there have been no studies on population-pharmacokinetic (pop-PK) modeling of epinastine focusing on genetic factors. The primary objective of this study was to quantitatively interpret the PK variability of epinastine according to phenotypic polymorphisms of cytochrome P450 (CYP) 2D6 in Korean population and to construct a new pop-PK model considering such polymorphisms. The bioequivalence PKs, physiologic and biochemical parameter analyses, and CYP2D6 genotyping results performed in 26 healthy Korean males were used in this study. The pop-PKs of epinastine were described by the first-order oral absorption and distribution between central and peripheral compartments, and elimination from the central compartment as the basic model structure. The covariate reflection of physiologic and biochemical parameters was not valid. Conversely, CYP2D6 phenotypic polymorphisms were explored as valid covariates for clearance from the central compartment (CL
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