Pharmacokinetics and bioavailability study of L-ornithine-L-aspartate in healthy volunteers--a comparative study of two oral formulations.

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.