Study on bioequivalence of domestic bambuterol capsules and imported tablets by high performance capillary zone electrophoresis / 药学学报
Acta Pharmaceutica Sinica
; (12): 942-945, 2003.
Article
in Zh
| WPRIM
| ID: wpr-301169
Responsible library:
WPRO
ABSTRACT
<p><b>AIM</b>To study bioequivalences of bambuterol and its metabolites terbutaline in 20 healthy male volunteers.</p><p><b>METHODS</b>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).</p><p><b>RESULTS</b>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).</p><p><b>CONCLUSION</b>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.</p>
Full text:
1
Index:
WPRIM
Main subject:
Tablets
/
Terbutaline
/
Blood
/
Capsules
/
Pharmacokinetics
/
Biological Availability
/
Therapeutic Equivalency
/
Administration, Oral
/
Chromatography, High Pressure Liquid
/
Cross-Over Studies
Type of study:
Clinical_trials
/
Prognostic_studies
Limits:
Adult
/
Humans
/
Male
Language:
Zh
Journal:
Acta Pharmaceutica Sinica
Year:
2003
Type:
Article