Bioavailabilities of commercially available VPA-Na in syrup (Depakene
®syrup, VPA-syr) and in fine granules (Hyserenin
®fine granules, VPA-FG) were compared.
Following oral administration of 15mg/kg of VPA-syr in single dose to 7 healthy male subjects at the age of 18 to 26, serum concentrations were determined by gas chromatography. After 7 days, VPA-FG was administered in the same dosage to the same subjects and the serum concentrations were measured. The results were analyzed in one-compartment open model.
Mean±S. D. of the maximum serum concentration level of VPA and the time required to achieve the level following administration of VPA-syr and VPA-FG were 31.9±20.3 min, 105.9±7.4μg/ml; and 24.8±3.8 min, 102.1±10.7μg/ ml, respectively, while the areas under the curve of the serum concentrations (AUC
0→∞) were 1602.2±219.8μg·hr/ ml for the former and 1554.6±192.1μg·hr/ ml for the latter. These results show that there is no statistically significant difference at the 5% significance level, and these drugs are equivalent preparations.
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