Pharmacokinetics of sibutramine hydrochloride in Chinese healthy volunteers.
- Author:
Jun CHEN
1
;
Wei LU
;
Xin-guo JIANG
;
Zheng-xing RONG
;
Xia HUANG
;
Hong-zhuan CHEN
Author Information
- Publication Type:Clinical Trial
- MeSH: Administration, Oral; Adult; Area Under Curve; Biological Availability; Chromatography, High Pressure Liquid; methods; Cross-Over Studies; Cyclobutanes; administration & dosage; blood; pharmacokinetics; Humans; Male; Serotonin Uptake Inhibitors; administration & dosage; pharmacokinetics; Spectrometry, Mass, Electrospray Ionization
- From: Acta Pharmaceutica Sinica 2003;38(11):850-853
- CountryChina
- Language:English
-
Abstract:
AIMTo evaluate the pharmacokinetic profiles of the pharmacologically active primary amine metabolite of sibutramine, N-di-desmethyl sibutramine (BTS 54505) in Chinese origin.
METHODSAccording to a randomized cross-over design, a single oral dose of 20 mg of sibutramine hydrochloride capsule was given to 20 healthy Chinese young volunteers. After dosing, serial blood samples were collected for a period of 72 h. BTS 54505 concentration in plasma was analyzed by high-performance liquid chromatography-electrospray ionization-tandem mass spectrometry.
RESULTSVarious pharmacokinetic parameters including AUC0-t, AUC0-infinity, Cmax, Tmax, T1/2, Kelm and MRT were determined for both test and reference capsules and found to be in good agreement with literature values.
CONCLUSIONThe test and reference sibutramine capsules were bioequivalent.
