Abstract
This study was conducted to predict the pharmacokinetics of oleanolic acid in humans based on animal data by allometry and several species-invariant time methods. Oleanolic acid was injected intravenously to mice, rats, rabbit and dogs (dose 1 mg/kg). The serum concentration-time profiles of oleanolic acid were best described by bi-exponential equation in all animal species. The average Cl, V ( ss ) and t ( 1/2 ) were 0.065 L/h, 0.019 L and 28.7 min in mice, 0.47 +/- 0.06 L/h, 0.117 +/- 0.029 L and 29.7 +/- 12.2 min in rats, 2.77 +/- 0.88 L/h, 1.83 +/- 0.60 L and 84.4 +/- 16.9 min in rabbits and 14.0 +/- 0.7 L/h, 9.2 +/- 10.1 L and 54.5 +/- 57.2 min in dogs, respectively. Based on animal data, human pharmacokinetic parameters of Cl, V ( ss ) and t (1/2) were predicted by simple allometry. In addition, actual concentration-time profiles obtained from animals were transformed to human profiles by species-invariant times of kallynochron, apolysichron and dienetichron. The predicted human pharmacokinetic parameters of Cl, V ( ss ) and t (1/2) by using simple allometry and species-invariant time transformation method ranged from 48.3-97.2 L/h, 49.1-92.9 L and 45.6-187.2 min, respectively. Those predicted parameters of oleanolic acid may be useful in designing dosing schedules of oleanolic acid in future clinical studies.
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