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The effect of Gender and ABCB1 Gene Polymorphism on the Pharmacokinetics of Azithromycin in Healthy Male and Female Pakistani Subjects.

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BACKGROUND In the current study, the possible outcome of sex difference and genotypic polymorphism of ABCB1 gene encoding p-glycoprotein (involved in biliary excretion of azithromycin) on the pharmacokinetics of azithromycin… Click to show full abstract

BACKGROUND In the current study, the possible outcome of sex difference and genotypic polymorphism of ABCB1 gene encoding p-glycoprotein (involved in biliary excretion of azithromycin) on the pharmacokinetics of azithromycin has been evaluated. METHODS An open-label, the comparative pharmacokinetic study was arranged by including female and male healthy Pakistani volunteers. They were administered with a single oral dose of azithromycin 500 mg. The blood samples (≈ 5 ml) were collected in heparinized tubes and HPLC/MS/MS method was used to determine azithromycin plasma levels. Student t-test was applied to compare pharmacokinetic parameters of azithromycin between male and female human subjects (at 95% CI) using Graph Pad prism8. RESULTS A significant difference was observed in PK parameters between males and females as Cmax in males (230 ±80.2 ng/ml) was significantly higher than females (224.9 ± 75.5 ng/ml), while was also significantly higher (p < 0.05) in males (2102 ± 200.3ng.hr/ml ) compared with females (1825.7 ± 225.4 ng.hr/ml). There was a significant variation in Cmax and AUC in three ABCB1 genotyping groups as well. CONCLUSION Gender difference and ABCB1 gene (encoding P-glycoprotein) polymorphisms have a significant impact on the pharmacokinetics of azithromycin as they contribute to inter-individual variability in therapeutic response.

Keywords: male female; pharmacokinetics azithromycin; abcb1 gene; pakistani; polymorphism

Journal Title: Canadian journal of physiology and pharmacology
Year Published: 2020

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