BIOEQUIVALENCE OF BAMBUTERAL AND ITS METABOLITES TERBUTALINE AFTER ORAL BAMBUTERAL TABLET IN HEALTHY VOLUNTEERS BY HPLC/MS / 药学学报

ABSTRACT

AIM　To study bioequivalence of bambuteral and its metablites terbutaline in 20 healthy male volunteers. METHODS　A single oral dose of domestic or imported bambuteral tablet was given according to a randomized 2-way cross-over design. The plasma bambuteral and terbutaline concentrations were determined by HPLC/MS. RESULTS　The pharmacokinetic parametrs of domestic and imported bambuteral AUC0-t were (52±21) μg*h*L-1 and (51±20) μg*h*L-1, Tmax were (2.9±0.9) h and (2.6±0.7) h, Cmax were (6.0±2.6) μg*L-1 and (6.2±2.9) μg*L-1, T1/2Ke were (11.2±2.3) h and (11.2±1.9) h, respectively; terbutaline AUC0-t were (191±30) μg*h*L-1 and (197±37) μg*h*L-1; Tmax were (4.2±1.0) h and (4.2±1.0) h; Cmax were (10±5) μg*L-1 and (10±4) μg*L-1; T1/2Ke were (20±3) h and (21±4) h, respectively. The bioavaiability of the domestics was 102%±8% (bambuteral) and 100%±12% (terbutaline). CONCLUSION　The results demonstrate that the two forms of bambuteral and terbutaline were bioequivalent by analysis of variance, two-one sided test and 90% confidential limit.