Effect of azvudine on the pharmacokinetics of ibuprofen in healthy volunteers
GONG Meng
LIU Xiao-jian
JU Hao-shuang
WAN Yuan-hao
DING Xue
ZHANG Sheng-bang
JIA Ya-qiang
ZHANG Wei
XU Ping
Abstract：Objective:To evaluate the effect of azvudine on the pharmacokinetics of ibuprofen in healthy volunteers.Methods:The study adopted a single-center,open,sequential dosing design and was conducted in 12 healthy volunteers.Subjects took ibuprofen(0.2 g,qd)for 5 consecutive days,followed by oral ibuprofen(0.2 g,qd)and azvudine(5 mg,qd)for 5 consecutive days,and plasma samples were collected for the determination of drug concentrations by high performance liquid chromatography-tandem mass spectrometry(LC-MS/MS).The main pharmacokinetic parameters were calculated by using Phoenix WinNonlin 8.3 and SAS 9.4.Results:The pharmacokinetic parameters of ibuprofen in plasma after administration of ibuprofen alone and co-administration with azvudine were as follows,Cmax,ss were(15 250.00±3 127.735)and(16 133.33±2 694.214)ng·mL-1,AUC0-t,ss were(69286.96±13927.273)and(73060.86±13060.975)ng·h·mL-1,AUC0-∞,ss were(72267.55±15 186.088)and(78 715.48±15 160.973)ng·h·mL-1.Compared with administration of ibuprofen alone,the 90%confidence intervals of the geometric mean ratios of Cmax,ss,AUC0-t,ss and AUC0-∞,ss of ibuprofen in plasma after co-administration with azvudine were 106.59%(93.02%～122.14%),105.81%(92.77%～120.67%),and 109.20%(94.91%～125.65%),respectively.Conclusion:The effect of azvudine on the pharmacokinetic profile of ibuprofen is consistent,without serious adverse events in healthy subjects.
Keywords：azvudineibuprofenpharmacokineticsLC-MS/MSdrug interaction
Publication Date：2025-12-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 2565-2569 )