The pharmacokinetics and bioequivalent evaluation of Compound Isoniazid tablet

OBJECTIVE To study the pharmacokinetics and relative bioavailability of two Compound Isoniazid tablets(Isoniazid plus Rifampicin).METHODS A single oral dose of the tested or the reference preparation was given to 24 volunteers in an open randomized cross over-test.The concentrations of Rifampicin and Isoniazid in plasma were assayed by RP-HPLC method.RESULTS The AUC 0→t of Rifampicin of the two preparations were 163.66±11.33 μg·h.ml -1 and 172.59±76.31 μg·h·ml -1,T max were 1.92±0.19 h and 1.96± 0.45 h,c max were 26.18±11.57 μg·ml -1 and 13.20±2.77 μg·ml -1,respectively.The AUC 0→t of Isoniazid were 44.26±5.84 μg·hml -1 and 46.68±16.60 μg·h·ml -1;T max were 1.83±0.33 h and 1.88±0.31 h;C max were 7.73±3.22 μg·ml -1 and 7.76±3.00 μg·ml -1,respectively.The result of statistical analysis showed that there were no significant difference of the lnAUC 0→t、T max and lnC max of Rifampicin and Isoniazid between the two preparations(P0.05).CONCLUSION The two preparations are bioequivalent using lnAUC 0→t、T max and lnC max of Rifampicin and Isoniazid as evaluated factors.The relative bioavailabilities of Rifampicin and Isoniazid of tested tablet are 95.86 %± 11.86% and 95.54%±12.53%,respectively.