Study on bioequivalence of domestic bambuterol capsules and imported tablets by high performance capillary zone electrophoresis.
- Author:
Ai-xin SHI
1
;
Ke-xin LI
;
Chun-hua SUN
;
Guo-ying CAO
Author Information
- Publication Type:Clinical Trial
- MeSH: Administration, Oral; Adult; Area Under Curve; Biological Availability; Capsules; Chromatography, High Pressure Liquid; Cross-Over Studies; Electrophoresis, Capillary; Humans; Male; Tablets; Terbutaline; administration & dosage; analogs & derivatives; blood; pharmacokinetics; Therapeutic Equivalency
- From: Acta Pharmaceutica Sinica 2003;38(12):942-945
- CountryChina
- Language:Chinese
-
Abstract:
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: AUC0-1 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).
CONCLUSIONThe 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.
