Study on the effect of different administration regimens of iprrazole enteric-coated tablets on inhibiting gastric acid secretion
10.13699/j.cnki.1001-6821.2024.01.019
- VernacularTitle:艾普拉唑肠溶片不同给药方案对其抑制胃酸分泌影响的研究
- Author:
Ting-Yuan PANG
1
;
Zhi WANG
;
Zi-Shu HU
;
Zi-Han SHEN
;
Yue-Qi WANG
;
Ya-Qian CHEN
;
Xue-Bing QIAN
;
Jin-Ying LIANG
;
Liang-Ying YI
;
Jun-Long LI
;
Zhi-Hui HAN
;
Guo-Ping ZHONG
;
Guo-Hua CHENG
;
Hai-Tang HU
Author Information
1. 广州医科大学附属肿瘤医院药学部,广东广州 510095
- Keywords:
iprrazole;
Chinese healthy subjects;
pH monitoring of gastric acid;
pharmacokinetics
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(1):92-96
- CountryChina
- Language:Chinese
-
Abstract:
Objective To compare the effects of 20 mg qd and 10 mg bidadministration of iprrazole enteric-coated tablets on the control of gastric acid in healthy subjects.Methods A randomized,single-center,parallel controlled trial was designed to include 8 healthy subjects.Randomly divided into 2 groups,20 mg qd administration group:20 mg enteric-coated tablets of iprrazole in the morning;10 mg bid administration group:10 mg enteric-coated tablets of iprrazole in the morning and 10 mg in the evening.The pH values in the stomach of the subjects before and 24 h after administration were monitored by pH meter.The plasma concentration of iprazole after administration was determined by HPLC-MS/MS.The main pharmacokinetic parameters were calculated by Phoenix WinNonlin(V8.0)software.Results The PK parameters of iprrazole enteric-coated tablets and reference preparations in fasting group were as follows:The Cmax of 20 mg qd group and 10 mg bid group were(595.75±131.15)and(283.50±96.98)ng·mL-1;AUC0-t were(5 531.94±784.35)and(4 686.67±898.23)h·ng·mL-1;AUC0-∞ were(6 003.19±538.59)and(7 361.48±1 816.77)h·ng·mL-1,respectively.The mean time percentage of gastric pH＞3 after 20 mg qd and 10 mg bid were 82.64％and 61.92％,and the median gastric pH within 24 h were 6.25±1.49 and 3.53±2.05,respectively.The mean gastric pH values within 24 h were 5.71±1.36 and 4.23±1.45,respectively.The correlation analysis of pharmacokinetic/pharmacodynamics showed that there was no significant correlation between the peak concentration of drug in plasma and the inhibitory effect of acid.Conclusion Compared with the 20 mg qd group and the 10 mg bid group,the acid inhibition effect is better,the administration times are less,and the safety of the two administration regimes is good.
