Effects of high-fat diet intake on pharmacokinetics of rabeprazole sodium enteric-coated tablets in healthy Chinese subjects
10.13699/j.cnki.1001-6821.2025.02.015
- VernacularTitle:高脂高热量饮食对中国健康受试者口服雷贝拉唑钠肠溶片药代动力学的影响
- Author:
Cai-hui GUO
1
;
Yu-fang XU
;
Cong-yang DING
;
Guang-tao HAO
;
Hao-jing SONG
;
Xue SUN
;
Zhan-jun DONG
;
Wan-jun BAI
Author Information
1. 河北省人民医院药学部河北省临床药学重点实验室,河北石家庄 050051
- Publication Type:Journal Article
- Keywords:
rabeprazole sodium enteric-coated tablet;
high-fat diet;
pharmacokinetics;
food effect;
liquid chromatography-tandem mass spectrometry
- From:
The Chinese Journal of Clinical Pharmacology
2025;41(2):225-229
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the effects of fasting and high-fat diet on the pharmacokinetics of rabeprazole sodium enteric-coated tablets in healthy Chinese subjects.Methods A single-center,randomized,open,two-agent,two-sequence,four-cycle,fully repeated crossover,single-dose trial design was used in this study,healthy subjects were assigned to receive single dose of rabeprazole sodium enteric-coated tablets 0.1 g in either fasting or high-fat diet state,and blood samples were taken at different time points,respectively.The concentrations of rabeprazole sodium enteric-coated in plasma were determined by liquid chromatography-tandem mass spectrometry(LC-MS/MS),the model method of the non-compartmental was used to calculate the pharmacokinetic parameters by Phoenix WinNonlin 8.2.Results The main pharmacokinetic parameters of rabeprazole sodium enteric-coated tablets in fasting state and high-fat diet state were as follows:Cmax were(339.63±156.47)and(318.86±132.13)ng·mL-1;t1/2 were(2.34±0.68)and(3.60±2.40)h;AUC0_t were(556.62±251.65)and(528.50±201.78)ng·mL-1·h;AUC0-∞ were(563.39±255.69)and(535.15±203.24)ng·mL-1·h;tmax were 3.65 and 6.99 h.After high-fat diet,the Cmax and AUC of rapeprazole sodium after high-fat and high-calorie diet decreased,Cmax decreased by 6.12％,AUC0-t decreased by 5.05％,AUC0-∞ decreased by 5.01％,andtmaxwas delayed by about 3.34 h.Cmax,AUC0-t and AUC0-∞ 90％confidence interval were 73.13％-115.10％,83.22％-112.28％and 83.40％-112.13％,respectively.Neither was between 85.00％-125.00％.Conclusion High-fat diet affects the absorption rate and degree of rabeprazole sodium enteric-coated,so it is suitable to be administered on an empty stomach.
