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OA

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.