Study on bioequivalent evaluation of Lifu Jiaonang in healthy volunteers

OBJECTIVE The pharmacokinetics and relative bioavailability of Lifu Jiaonang were studied. METHOD Isoniazid and rifampicin were determined after a single oral dose of testing preparation Lifu Jiaonang 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-HPLC method.RESULTS The AUC 0→∞ of rifampicin of the two formations were (62.28± 18.22)μg·h·mL -1 and (59.53±18.75)μg·h·mL -1 ; T max were (2.02±0.38)h and (2.02±0.35)h;C max were (13.20±2.77)μg·mL -1 and (13.23±3.55)μg·mL -1 respectively. The AUC 0→∞ of isoniazid of the two formations were (12.73±4.53)μg·h·mL -1 and (15.85±4.97)μg·h·mL -1 ; T max were (1.71±0.25)h and (1.85±0.35)h;C max were (4.39±1.47)μg·mL -1 and (5.36±1.55)μg·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(P0.05). CONCLUSION Lifu Jiaonang tablet and Rifinah tablets were bioequivalent using AUC 0→∞ 、T max and C max of isoniazid and rifampicin as evaluated factors, the bioequivalence of rifampicin and isoniazid of Lifu Jiaonang were (105.85±11.67)% and (102.81±15.42)% using Rifinah tablet as standard preparation.