Title: Study on bioequivalence of rosiglitazone sodium tablets in healthy volunteers
Abstract: Objective:To evaluate the bioequivalence of two rosiglitazone sodium tablets in healthy volunteers.Method:In a randomized,crossover and self-control study,20 healthy male volunteers were orally administrated with rosiglitazone sodium tablets 8 mg.The plasma concentration of rosiglitazone was determined by RP-HPLC with fluorimetric detection.Results:The main pharmacokinetic parameters of the test and reference preparation were as follows:Tmax (2.00±0.00) and (2.16±1.27)h;Cmax (743.54±173.23) and (707.68±77.62)ng·mL-1;t1/2 (3.70±0.63) and (3.46±2.18)h;AUC 0~24 (2811.46±151.23) and (2473.04±75.07)ng·h·mL-1;AUC 0~∞(2947.53±164.77) and (2489.19±99.25)ng·h·mL-1,respectively.The relative bioavailability of Rosiglitazone sodium tablets was (105.97±18.82)%.Conclusion:The results of statistic analysis showed that the two preparations were bioequivalent.
Publication Year: 2009
Publication Date: 2009-01-01
Language: en
Type: article
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