Study on Bioequivalent Evaluation of LIFU Tablet in Healthy Volunteers

Objective:To study pharmacokinetics and relative bioavaiability of LIFU.Methods:Isoniazid and Rifampicin were determined after a single oral dose of testing preparation LIFU and standard preparation Rifinah were given respectively to 24 volunteers in an open randomized cross over test.Isoniazid and Rifampicin concentration in plasma were assayed by RP HPLE method.Results:The AUC 0→∞ of Rifampicin of the two formations were 60.79±18.82μg·ml -1 ·h and 59.53±18.75μg·ml -1 ·h;T max were 1.94±0.27 h and 2.02±0.35h;C max were 13.11±3.48μg·ml -1 and 13.23±3.55μg·ml -1 ,respectively.The AUC 0→∞ of Isoniazid of the two formations were 12.13±3.69μg·ml -1 ·h and 15.85±4.97μg·ml -1 ·h;T max wre 1.73±0.25 h and 1.85±0.35h;C max were 4.36±1.43μg·h·ml -1 and 5.36±1.55μg·ml -1 respectively.The result of statistical analysis showed that there were no significant difference of the AUC 0→∞ 、T max and C max of Isoniazid and Rifampicin between the two formations( P 0.05).LIFU and Rifinah tablets were bioequivalent using Isoniazid and Rifampicin as evaluated factors.Conclusion:The bioequivalence fo Rifampicin and Isoniazid of LIFU are 102.58±9.33% and 103.39±12.05% using Rifinah tablet as standard preparation.