Title: Study on Bioequivalence of Sodium Valproic Sustained-Release Compound Tablets in Healthy Volunteers
Abstract: OBJECTIVE: To evaluate relative bioavailability of domestic and imported sodium valproic sustained-release compound tablets in healthy volunteers. METHODS: A single and a multi oral administration of 500mg domestic and imported sodium valproic sustained-release compound tablets were given to two group 20 healthy male volunteers in randomized crossover study respectively. A high performance liquid chromatographic assay with fluorimetric detection was developed to determine the concentration of sodium valproic in human serum. The data were analyzed by 3P97 program. RESULTS: The pharmacokinetics parameters after a single oral administration of 500mg domestic and imported products were as follows: Cmax 36.45±6.57 and 34.40±4.66 mg·L-1; Tmax 11.20±1.60 and 10.20±2.75h; AUC0-∞ 1329.87±397.49 and 1243.43±360.00mg.L-1.h, 108.38±19.95% respectively. The pharmacokinetics parameters after a multi oral administration of 500mg domestic and imported products were as follows: Cmax 59.05±10.67 and 60.69±14.81 mg.L-1; Cmin 38.17±9.36 and 35.48±9.44 mg.L-1; Tmax 8.80±3.43 and 7.75±3.16h; DF% 44.95±15.48% and 53.99±17.41%; AUCss0-? 1154.94±237.05 and 1142.82±293.71mg.L-1.h respectively. Variance analysis and two one-sided test were performed to parameters: Cmax, AUC0-∞ of single oral administration group and parameters: Cmax, AUCss0-? of multi oral administration group. There were no significant difference. CONCLUSION: The two preparations were of bioequivalence, the relative bioavailabilities of single oral administration group and multi oral administration group were 108.38±19.95% and 105.42±24.36% respectively.
Publication Year: 2000
Publication Date: 2000-01-01
Language: en
Type: article
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