Study on bioequivalence of domestic bambuterol capsules and imported tablets by high performance capillary zone electrophoresis

AimTo study bioequivalences of bambuterol and its metabolites terbutaline in 20 healthy male volunteers. MethodsA single oral dose of domestic bambuterol capsule or imported bambuterol tablet was given according to a randomized 2-way cross-over design. The plasma bambuterol and terbutaline concentrations were determined by high performance capillary zone electrophoresis (HPCZE). ResultsThe pharmacokinetic parameters of the capsule and tablet of bambuterol: AUC0-t were (72±18) and (72±13) μg·h·L^-1, C_max were (8.1±1.8) and (9.2±2.3) μg·L^-1, t_max were (3.6±1.3) and (3.7±1.0) h, respectively; terbutaline: AUC0-t were (129±32) and (130±34) μg·h·L^-1, C_max were (7.8±2.2) and (8.5±2.9) μg·L^-1, t_max were (5.4±0.8) and (5.6±1.1) h, respectively. The bioavaiability of the capsule was (100±16)% (bambuterol) and (101±13)% (terbutaline). Conclusion The results demonstrated that the two preparations of bambuterol and terbutaline were bioequivalent by analysis of variance, with two-one sided test at 90% confidential level.