Title: Bioequivalence of Cefixime tablets in healthy volunteers
Abstract: OBJECTIVE To study the bioequivalence of Cefixime tablets in healthy volunteers.METHODS Cefixime concentrations in serum were determined by HPLC after single oral dose of 200 mg of Cefixime tablets or reference Cefixime tablets which were given to 20 healthy male volunteers in a randomized cross-over design.The pharmacokinetic parameters and relative bioavailability were calculated by NDST-21 program to evaluate the bioequivalence of two preparations.RESULTS AUC (0 t) of the reference and the test drug were 35.468±12.863 mg·h·L -1and 33.098±11.699 mg·h·L -1,respectively.C max of each group were 3.682±1.355 mg·L -1 and 3.364±1.206 mg·L -1,respectively. T max were 4.55±0.83 h and 4.60±0.94 h,respectively.CONCLUSION The two preparations are bioequivalent.The relative bioavailabity of the test drug was 107.98%±15.76%.
Publication Year: 2005
Publication Date: 2005-01-01
Language: en
Type: article
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