Bioequivalence study of nimesulide dispersible tablets in Chinese healthy subjects
10.13699/j.cnki.1001-6821.2024.21.015
- VernacularTitle:尼美舒利分散片在中国健康受试者中的生物等效性研究
- Author:
Bo-yang LIN
1
;
Rong HU
;
Wang-gang ZHANG
;
Jing YAN
Author Information
1. 浙江中医药大学研究生院,浙江 杭州 310053;浙江医院Ⅰ期临床试验研究室,浙江 杭州 310030
- Publication Type:Journal Article
- Keywords:
nimesulide dispersible tablets;
bioequivalence;
safety evaluation;
liquid chromatography-tandem mass spectrometry
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(21):3142-3146
- CountryChina
- Language:Chinese
-
Abstract:
Objective To compare the pharmacokinetic parameters of nimesulide dispersible tablets(test preparation)and nimesulide tablets(reference preparation)in Chinese healthy subjects and to evaluate the bioequivalence of two formulations.Methods This trial used a single-centre,randomised,open,two-preparation,two-cycle,two-way crossover experimental design.28 subjects were enrolled under fasting and fed conditions,who received a single oral dose of 0.1 g of nimesulide in the test or reference formulation each cycle.Plasma nimesulide concentration was determined by liquid chromatography-tandem mass spectrometry(LC-MS/MS),calculation of pharmacokinetic parameters and bioequivalence evaluation.Results In fasting group,main pharmacokinetic parameters of the subject and reference formulations of nimesulide:Cmax were(6 262.14±1 213.98)and(6 625.36±1 230.09)ng·mL-1,AUC0-t were(4.48 × 104±1.66 × 104)and(4.50 × 104±1.53 × 104)h·ng·mL-1,AUC0-∞ were(4.60 × 104±1.83 × 104)and(4.62 × 104±1.68 × 104)h·ng·mL-1.In fed group,main pharmacokinetic parameters of the subject and reference formulations of nimesulide:Cmax were(6 934.29±1 371.00)and(6 551.85±1 383.91)ng·mL-1,AUC0-t were(4.43 × 104±1.52 × 104)and(4.50 × 104±1.47 × 104)h·ng·mL-1,AUC0-∞ were(4.56 × 104±1.67 × 104)and(4.64 × 104±1.60 × 104)h·ng·mL-1.The 90％confidence intervals for the geometric means of Cmax,AUC0-t,AUC0-∞ for reference and test preparations in the fasting and fed groups were in the range of 80.00％to 125.00％.The incidence of adverse events in both fasting and fed trials was 25.00％(7 cases/28 cases).Conclusion Nimesulide dispersible tablets were bioequivalent to the reference formulation nimesulide tablets in Chinese healthy subjects when taken under both fasting and fed conditions.
