中国临床药理学杂志2024，Vol.40Issue(1)：102-106,5.DOI:10.13699/j.cnki.1001-6821.2024.01.021
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
Effect of high fat diet intake on pharmacokinetics of metronidazole tablets in healthy Chinese volunteers
赵娜 1郭彩会 1刘亚丽 2宋浩静 1史犇 3胡义亭 1贾彩云 1董占军1
作者信息
- 1. 河北省人民医院Ⅰ期临床研究室,河北石家庄 050051
- 2. 石家庄四药有限公司,河北石家庄 050051
- 3. 苏州国辰生物科技股份有限公司,江苏苏州 215104
- 折叠
摘要
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.关键词
甲硝唑片/高脂饮食/药代动力学/食物效应Key words
metronidazole/high-fat diet/pharmacokinetics/food effect分类
医药卫生引用本文复制引用
赵娜,郭彩会,刘亚丽,宋浩静,史犇,胡义亭,贾彩云,董占军..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[J].中国临床药理学杂志,2024,40(1):102-106,5.
