[Bioequivalence of bambuteral and its metabolites terbutaline after oral bambuteral tablet in healthy volunteers by HPLC/MS].
OBJECTIVE
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 parameters of domestic and imported bambuteral: AUC0-t were (52 +/- 21) microgram.h.L-1 and (51 +/- 20) microgram.h.L-1, Tmax were (2.9 +/- 0.9) h and (2.6 +/- 0.7) h, Cmax were (6.0 +/- 2.6) microgram.L-1 and (6.2 +/- 2.9) microgram.L-1, T1/2Ke were (11.2 +/- 2.3) h and (11.2 +/- 1.9) h, respectively; terbutaline: AUC0-t were (191 +/- 30) microgram.h.L-1 and (197 +/- 37) microgram.h.L-1; Tmax were (4.2 +/- 1.0) h and (4.2 +/- 1.0) h; Cmax were (10 +/- 5) microgram.L-1 and (10 +/- 4) microgram.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).


CONCLUSIONS
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.
Sun
C H
CH
Clinical Pharmacology Base, Beijing Hospital, Beijing 100730, China. sunchunhh@sina.com
Liu
L
L
Yin
Q
Q
D000284:Administration, Oral; D000318:Adrenergic beta-Agonists / Q000097:blood / Q000378:metabolism / Q000493:pharmacokinetics; D000328:Adult; D019540:Area Under Curve; D001682:Biological Availability; D001993:Bronchodilator Agents / Q000378:metabolism / Q000493:pharmacokinetics*; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D008401:Gas Chromatography-Mass Spectrometry; D006801:Humans; D008297:Male; D013607:Tablets; D013726:Terbutaline / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000097:blood / Q000378:metabolism / Q000493:pharmacokinetics*
D000318:Adrenergic beta-Agonists; D001993:Bronchodilator Agents; D003692:Delayed-Action Preparations; D013607:Tablets; D013726:Terbutaline; C047766:bambuterol