Pharmacokinetics of sibutramine hydrochloride in Chinese healthy volunteersPharmacokinetics of sibutramine hydrochloride in Chinese healthy volunteers

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 AUC_0-t, AUC_0-∞,　C_max, T_max, T_1/2, K_elmand 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.