Pharmacokinetics of sibutramine hydrochloride in Chinese healthy volunteers / 药学学报

ABSTRACT

<p><b>AIM</b>To evaluate the pharmacokinetic profiles of the pharmacologically active primary amine metabolite of sibutramine, N-di-desmethyl sibutramine (BTS 54505) in Chinese origin.</p><p><b>METHODS</b>According 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.</p><p><b>RESULTS</b>Various 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.</p><p><b>CONCLUSION</b>The test and reference sibutramine capsules were bioequivalent.</p>