Abstract
The pharmacokinetic (PK) of omeprazole (OMP), 5-hydroxy-omeprazole (5-OH-OMP) and omeprazole sulphone (OMP-SUL), was investigated in healthy premenopausal and postmenopausal females. A single oral dose, open-label, non-controlled, pharmacokinetic study was conducted in healthy premenopausal (n = 16) and postmenopausal (n = 8) females. The samples were analyzed using reversed phase high performance liquid chromatography (HPLC), different pharmacokinetics (PK) parameters were determined and compared statistically to evaluate the difference between two groups. The activities of CYP2C19 and CYP3A4 were determined as AUCOMP/AUCOH-OMP and AUCOMP /AUCOMP-SUL, respectively. The significant differences (P < 0.05) between Cmax, tmax, [AUC]to, [AUC]ooo, t1/2 and metabolic ratios (MR) of OMP, 5-OH-OMP and OMP-SUL were observed between premenopausal and postmenopausal females. The present studies showed the higher AUC and longer t1/2 in postmenopausal subjects. The increase in MR for 5–OH-OMP and also OMP-SUL determined as AUCOH-OMP/AUCOMP and AUCOMP-SUL/AUCOMP, respectively, was also observed in postmenopausal females compared with the premenopausal females. Key words: Omeprazole, pharmacokinetics, menopause.
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