Bioequivalence of compound rifampicin tablets in healthy volunteers

Objective:To study the pharmacokinetic profiles and bioequivalence of domestic and imported compound rifampicin tablets in healthy volunteers.Methods:The drug concentration in plasma were assayed by RP HPLC method following a single oral of three tablets of domestic rifampicin or imported rifampicin.Results:The pharmacokinetics parameters of rifampicin were as follows: T max were(1.17±0.44) and (1.24±0.46)h, t 1/2ke were (6.55±1.97) and(6.41±1.96)h, C max were (9.78± 3.45) and (9.71±3.17)mg·L -1 ,AUC 0～24 were(35.61±13.40 ) and(35.14±12.98)mg·h·L -1 ,the relative bioavailability of rifampicin in domestic tablets were(101.34± 13.12)%. The pharmacokinetics parameters of isoniazid were as follows: T max were(0.80±0.18) and (0.81±0.27)h,t 1/2ke were(2.96±0.86) and (3.53±2.62)h, C max were(5.71±2.10) and( 5.31±1.84)mg·L -1 ,AUC 0～12 were(13.95±3.43 ) and (14.11±4.11)mg·h·L -1 ,the relative bioavailability in isoniazid of domestic tablets were(98.87±12.50)%.Two formulations of rifampicin tablets were bioequivalent by analysis of variance,two one sided test and 90% confidential interal.Conclusion:The imported and domestic compound rifampicin tablets are of bioequivalence.