Effect of high-fat meal on the pharmacokinetics of dexamethasone in healthy Chinese volunteers / 国际药学研究杂志

ABSTRACT

Objective: To investigate the differences in the pharmacokinetics of dexamethasone between fasting and high-fat meals in Chinese volunteers. Methods:Twenty volunteers were given a 1.5 mg dose of dexamethasone tablets before and after a high-fat meal. After the plasma sample was prepared by protein precipitation, the plasma concentration of dexamethasone was determined by LC-MS/MS. The main pharmacokinetic parameters were calculated with DAS 3.2.1 software. The statistical analysis was carried out with SPSS 24 software. Results:The calibration curve for dexamethasone in human plasma showed a good linearity within the concentration range of 0.100-20.0 μg/L. The main pharmacokinetic parameters of dexamethasone for the fasting and high-fat meal conditions were as follows C max (17.79±4.44)and(12.95±4.05)μg/L, T max (0.78±0.49)and(1.58±0.91)h, t 1/2(4.15±0.90)and(4.88±1.35) h, AUC 0-t (62.08±14.23)and(75.84±26.84)μg•h/L, AUC 0-∞ (63.29±15.13)and(79.58±30.33)μg•h/L, MRT 0-t (4.90±0.82)and (5.93±1.11)h, and MRT 0-∞ (5.39±1.06)and(6.93±1.83)h, respectively. The t-test results showed that there were significant differences in T max, C max, MRT 0-t and MRT 0-∞ (P0.05)between the fasting and high-fat meal groups. Conclusion:High-fat meals could significantly delay the time to reach maximum concentration, increase the mean residence time and reduce the peak concentration of dexamethasone, but does not influence the exposure amount.