[Study on bioequivalence of domestic bambuterol capsules and imported tablets by high performance capillary zone electrophoresis].
OBJECTIVE
To study bioequivalences of bambuterol and its metabolites terbutaline in 20 healthy male volunteers.


METHODS
A 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).


RESULTS
The pharmacokinetic parameters of the capsule and tablet of bambuterol: AUC0-1 were (72 +/- 18) and (72 +/- 13) microgram.h.L-1, Cmax were (8.1 +/- 1.8) and (9.2 +/- 2.3) microgram.L-1, Tmax were (3.6 +/- 1.3) and (3.7 +/- 1.0) h, respectively; terbutaline: AUC0-t were (129 +/- 32) and (130 +/- 34) microgram.h.L-1, Cmax were (7.8 +/- 2.2) and (8.5 +/- 2.9) microgram.L-1, Tmax 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).


CONCLUSIONS
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.
Shi
Ai-xin
AX
Department of Clinical Pharmacology, Beijing Hospital, Beijing 100730, China. aixins@sohu.com
Li
Ke-xin
KX
Sun
Chun-hua
CH
Cao
Guo-ying
GY
D000284:Administration, Oral; D000328:Adult; D019540:Area Under Curve; D001682:Biological Availability; D002214:Capsules; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D019075:Electrophoresis, Capillary; D006801:Humans; D008297:Male; D013607:Tablets; D013726:Terbutaline / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency
D002214:Capsules; D013607:Tablets; D013726:Terbutaline; C047766:bambuterol