中国当代医药2026，Vol.33Issue(4)：39-43,5.DOI:10.3969/j.issn.1674-4721.2026.04.07
马尿酸乌洛托品片在中国健康受试者中的生物等效性研究
Bioequivalence study of Methenamine Hippurate Tablets in healthy Chi-nese subjects
丁峰 1王定淼 2饶夏莉 2尹咸淼 1宋欢 1陈连连 1靳飞 1华美霞2
作者信息
- 1. 湖北科技学院医学部药学院,湖北 咸宁 437100
- 2. 湖北科技学院附属第一医院 湖北省咸宁市中心医院Ⅰ期临床研究中心,湖北 咸宁 437100
- 折叠
摘要
Abstract
Objective The pharmacokinetic characteristics of a single-dose oral administration of Methenamine Hippurate Tablets in healthy subjects under fasting and postprandial conditions were studied to further evaluate bioequivalence and safety.Methods A single-center,randomized,open-label,single-dose,two-formulation,two-sequence,two-period crossover design was adopted.Twenty-four healthy Chinese subjects meeting the inclusion criteria from Xiangning Central Hospital in June 2024 were selected as the research subjects.These subjects were randomly assigned to the fasting group(12 cases)and the postprandial group(12 cases),and orally administered the test formulation T(1 g)or the reference formulation R(1 g)of Methenamine Hippurate under fasting and postprandial conditions.The concentration of Hippurate in human plasma was detected by liquid chromatography-mass spectroscopy/mass spectroscopy(LC-MS/MS),and the pharmacokinetic parameters of Methenamine Hippurate were calculated using WinNonlin statistical software.Results The Cmax,AUC0-t,and AUC0-∞of Hippurate in the test formulation and reference formulation under fasting conditions were(41950±3 200)and(40 120±3100)ng/ml,(229000±15 000)and(209 500±16 800)h/(ng·ml),and(239,500±15 200)and(218 000±17 300)h/(ng·ml),respectively,and the Cmax,AUC0-t,and AUC0-∞of Hippurate in the test formulation and reference formulation under post-prandial conditions were(25050±2 600)and(25 800±2 300)ng/ml,(192 500±13 300)and(196 000±14 200)h/(ng·ml),and(201000±13 700)and(204 500±14 000)h/(ng·ml),respectively.The 90%confidence intervals of the least squares geometric mean ratios of the pharmacokinetic parameters were all within 80%to 125%.Conclusion Methenamine Hippu-rate Tablets are bioequivalent in terms of absorption speed and absorption degree under fasting and postprandial conditions for both formulations.关键词
马尿酸乌洛托品/药代动力学/生物等效性研究/双峰现象Key words
Methenamine Hippurate/Pharmacokinetic/Bioequivalence study/Double peak phenomenon分类
医药卫生引用本文复制引用
丁峰,王定淼,饶夏莉,尹咸淼,宋欢,陈连连,靳飞,华美霞..马尿酸乌洛托品片在中国健康受试者中的生物等效性研究[J].中国当代医药,2026,33(4):39-43,5.
