生物等效性
生物利用度
药代动力学
最大值
化学
交叉研究
置信区间
药理学
色谱法
方差分析
口服
内科学
医学
安慰剂
病理
替代医学
作者
Piotr Kowalski,Michał Bieniecki
标识
DOI:10.1016/j.jpba.2006.01.049
摘要
The aim of the evaluation was to establish bioequivalence between two oral 3.0 g sachet forms of L-ornithine-L-aspartate (LOLA). It was designed as randomised, two-way crossover study with a 1-week washout interval. Blood samples were collected throughout a 12 h period after administration of reference and test product to 12 fasting healthy male volunteers. Plasma were analyzed by sensitive, reproducible, accurate and rapid capillary electrophoresis (CE) method with UV detection. Many pharmacokinetic parameters including AUC0-t, AUC0-infinity, Cmax, Tmax, T1/2 and Kel were determined from plasma concentration. First three of them after log-transformation of data were examined for bioequivalence. Based on ANOVA with 90% confidence level no significant difference was found. All of tested parameters were found to be within the bioequivalence acceptance range of 80-125%. Based on these and other statistical tests it was concluded that Hepatil is bioequivalent to Hepa-Merz granulate.
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