Effect of high-fat diet intake on pharmacokinetics of amoxicillin and clavulanate potassium tablet in healthy Chinese volunteers
10.13699/j.cnki.1001-6821.2024.04.023
- VernacularTitle:高脂饮食对阿莫西林在中国健康人体内药代动力学的影响
- Author:
Yu-Fang XU
1
,
2
;
Hao-Jing SONG
;
Bo QIU
;
Yi-Ting HU
;
Wan-Jun BAI
;
Xue SUN
;
Bin CAO
;
Zhan-Jun DONG
Author Information
1. 河北省人民医院 药学部,河北 石家庄 050051
2. 河北省临床药学重点实验室,河北石家庄 050051
- Keywords:
amoxicillin and clavulanate potassium;
high-fat diet;
pharmacokinetics;
bioequivalence;
food effect
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(4):589-593
- CountryChina
- Language:Chinese
-
Abstract:
Objective To observe the pharmacokinetic effect of amoxicillin and clavulanate potassium tablets on amoxicillin in Chinese healthy subjects under fasting and high fat and high calorie diet.Methods 71 healthy subjects were given a single dose of amoxicillin potassium clavulanate tablets(0.375 g)on fasting or high fat diet,and venous blood samples were collected at different time points.The concentrations of amoxicillin in human plasma were determined by HPLC-MS/MS method,and the pharmacokinetic parameters were calculated by non-atrioventricular model using PhoenixWinNonlin 8.0 software.Results The main pharmacokinetic parameters of amoxicillin potassium clavulanate tablets after fasting and high fat diet were(5 105.00±1 444.00),(4 593.00±1 327.00)ng·mL-1,and postprandial-fasting ratio 89.40％,90％confidence interval(79.55％-100.19％);t1/2 were(1.52±0.16),(1.39±0.22)h;AUC0-t were(12 969.00±1 841.00),(11 577.00±1 663.00)ng·mL-1·h,and postdietary/fasting ratio 89.20％,90％confidence interval(83.92％-94.28％);AUC0-∞ were(13 024.00±1 846.00),(11 532.00±1 545.00)ng·mL-1·h,and postprandial-fasting ratio 88.60％,90％confidence interval(83.48％-93.50％).The median Tmax(range)were 1.63(0.75,3.00)and 2.50(0.75,6.00)h,respectively,and the Tmax of postprandial medication was delayed(P＜0.01).Conclusion Compared with fasting condition,amoxicillin Tmax was significantly delayed after high fat diet,while Cmax,AUC0-t and AUC0-∞ were not significantly changed,indicating that food could delay the absorption of amoxicillin,but did not affect the degree of absorption.
