中国临床药理学杂志2024，Vol.40Issue(1)：107-111,5.DOI:10.13699/j.cnki.1001-6821.2024.01.022
精氨酸布洛芬颗粒在中国健康受试者中的生物等效性研究
Bioequivalence of ibuprofen arginine granules in healthy Chinese volunteers
石盼盼 1沈芬 1宋丽梅 1赵丰丽 1李望 2张伟臣 2田禹2
作者信息
- 1. 山西省运城市中心医院药物临床试验中心,山西运城 044000
- 2. 海南葫芦娃药业集团股份有限公司,海南海口 570000
- 折叠
摘要
Abstract
Objective To evaluate the bioequivalence and safety of ibuprofen arginine granules test and reference formulations in Chinese healthy volunteers under fasting and postprandial conditions,and to provide evidence for consistency evaluation and clinical application of the drugs.Methods A single-center,single-dose,randomized,open-label,fasting and postprandial,two-period,two-crossover trial design was used.Twenty-four healthy Chinese volunteers were enrolled in the fasting and postprandial trial,respectively.The test preparation and reference preparation of ibuprofen arginine granules 0.4 g were taken orally in a randomized crossover single dose.Data analysis was performed using Phoenix WinNonlin 8.3.Results In the fasting group,the main pharmacokinetic parameters of ibuprofen in plasma after administration of the test and reference formulations of ibuprofen arginine granules were as follows:Cmax were(51.07±7.43)and(50.10±7.64)μg·mL-1;AUC0-,were(122.78±20.62)and(119.94±21.03)μg·h·mL-1;AUC0_∞ were(125.84±21.31)and(122.64±21.87)μg·h·mL-1,respectively.In the postprandial group,the main pharmacokinetic parameters of ibuprofen in plasma after administration of the test and reference formulations of ibuprofen arginine granules were as follows:Cmax were(17.47±3.56)and(17.89±4.47)μg·mL-1;AUC0-twere(114.33±17.12)and(122.13±29.46)μg·h·mL-1;AUC0_∞ were(134.04±36.72)and(133.96±30.35)μg·h·mL-1,respectively.The 90％confidence intervals of the geometric mean ratio of the two preparations were as follows:Cmax 97.96％-106.02％,AUC0_t 98.77％-105.14％,AUC0-∞ 99.34％-105.19％in fasting group;in postprandial group,Cmax was 92.37％-103.05％,AUC0-t was 93.31％-99.56％,AUC0-∞ was 93.89％-102.91％.Conclusion The test preparation and reference preparation of ibuprofen arginine granules in this study are bioequivalent in healthy adult Chinese volunteers.关键词
精氨酸布洛芬/健康受试者/药代动力学/高效液相色谱-质谱联用法/生物等效性Key words
ibuprofen arginine granules/healthy volunteers/pharmacokinetic/high performance liquid chromatography-mass spectrometry(HPLC-MS/MS)/bioequivalence分类
医药卫生引用本文复制引用
石盼盼,沈芬,宋丽梅,赵丰丽,李望,张伟臣,田禹..精氨酸布洛芬颗粒在中国健康受试者中的生物等效性研究[J].中国临床药理学杂志,2024,40(1):107-111,5.
