Title: Pharmacokinetics and relative bioavailability of domestic glimepiride tablets
Abstract: Objective:To study the pharmacokinetics and relative bioavailability of glimepiride tablet.Methods:The bioequivalence and relative bioavailability of a test domestic formulation of glimepiride in comparison with a reference imported formulation was investigated in a randomized 2 way cross over study in 20 healthy volunteers following a single oral dose of 4mg.The washout period is one week.Plasma concentrations of glimepiride were determined by a HPLC system equipped with ultraviolet detection.Results:The following pharmacokinetic parameters were derived from the individual plasma concentration time courses,and the main parameters for test and reference formulations were as follows: C max were (462.3±132.2) and (412.4±117.7)μg·L -1 ; T max were (3.2±0.6) and (3.3±0.8) h; t 1/2 were (7.1±1.5) and (7.5±1.7) h;AUC 0~t were (2 571.6±564.9) and (2 362.3 ±519.6) μg·h·L -1 ;AUC 0~∞ were (2 769.8±608.2) and (2 592.4±572.5)μg·h·L -1 ,respectively.Compared with reference formulation, the relative bioavailability of test formulation was (111.3± 23.3)%. The above parameters obtained from two formulations were compared by analysis of variance (ANOVA) and no significant differences were found.Conclusion:The test formulation is bioequivalent with the reference formulation.
Publication Year: 2003
Publication Date: 2003-01-01
Language: en
Type: article
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