Effect of high fat diet intake on pharmacokinetics of metronidazole tablets in healthy Chinese volunteers
10.13699/j.cnki.1001-6821.2024.01.021
- VernacularTitle:高脂高热量饮食对中国健康受试者口服甲硝唑片药代动力学的影响
- Author:
Na ZHAO
1
;
Cai-Hui GUO
;
Ya-Li LIU
;
Hao-Jing SONG
;
Ben SHI
;
Yi-Ting HU
;
Cai-Yun JIA
;
Zhan-Jun DONG
Author Information
1. 河北省人民医院Ⅰ期临床研究室,河北石家庄 050051
- Keywords:
metronidazole;
high-fat diet;
pharmacokinetics;
food effect
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(1):102-106
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the effects of high-fat diet on the pharmacokinetics of metronidazole in Chinese healthy adult subjects.Methods This program is designed according to a single-center,randomized,open,single-dose trial.Forty-seven healthy subjects were assigned to receive single dose of metronidazole tablets 200 mg in either fasting and high-fat diet state,and blood samples were taken at different time points,respectively.The concentrations of metronidazole in plasma were determined by high performance liquid chromatography-mass spectromentry.Results The main pharmacokinetic parameters of metronidazole in fasting state and high-fat diet state were as follows:Cmax were(4 799.13±1 195.32)and(4 044.17±773.98)ng·mL-1;tmax were 1.00 and 2.25 h;t1/2 were(9.11±1.73)and(9.37±1.79)h;AUC0_t were(5.59±1.19)x 104 and(5.51±1.18)x 104 ng·mL-1·h;AUC0_∞ were(5.79±1.33)x 104 and(5.74±1.32)× 104 ng·mL-1·h.Compared to the fasting state,the tmaxof the drug taken after a high fat diet was delayed by 1.25 h(P＜0.01),Cmax,AUC0_t,AUC0-∞ were less or decreased in different degrees,but the effects were small(all P＞0.05).Conclusion High-fat diet has little effects on the pharmacokinetic parameters of metronidazole,which does not significantly change the degree of drug absorption,but can significantly delay the time to peak.
