comparative pharmacokinetic study between metformin alone and combined with orlistat in healthy mexican volunteers比较药代动力学研究与二甲双胍单独加上墨西哥奥利司他在健康志愿者.pdfVIP

Pharmacology Pharmacy, 2012, 3, 300-306 /10.4236/pp.2012.33040 Published Online July 2012 (http://www.SciRP.org/journal/pp) Comparative Pharmacokinetic Study between Metformin Alone and Combined with Orlistat in Healthy Mexican Volunteers 1 2,3 Noemí Santos-Caballero , Francisco Javier Flores-Murrieta 1Landsteiner Scientific, S.A. de C.V., México, D.F., Mexico; 2Sección de Estudios de Posgrado e Investigación, Escuela Superior de Medicina, Instituto Politécnico Nacional, México, D.F., Mexico; 3Unidad de Investigación en Farmacología, Insituto Nacional de Enfermedades Respiratorias “Ismael Cosio Villegas”, México, D.F., Mexico. Email: nsantos@, nsantoscaballero@ Received March 8th, 2012; revised April 20th, 2012; accepted May 8th, 2012 ABSTRACT Traditional treatment of type 2 diabetes mellitus (T2DM) has focused on correcting hyperglycemia. However, T2DM is almost always accompanied by other conditions and risk factors that affect its morbidity and mortality. Obesity repre- sents one of the main risk factors associated in the T2DM and a modest weight loss around 5% is linked with significant reduction in the blood glucose levels. The objective of this study was to compare the pharmacokinetic parameters be- tween two formulations of metformin, alone or combined with orlistat, in healthy volunteers. A single-blinded, single dose, two-period, two-sequence, crossover, randomized and balanced study design with a 7-day washout period was performed in 26 Mexican volunteers. Plasma samples were collected over a 24-hour period after administration of 500 mg metformin alone or combined with 60 mg orlistat in each period. A validated high-performance liquid chromatog- raphy coupled with an ultraviolet detector was used to analyze metformin concentration in plasma. Bioequivalence be- tween metformin alone and metformin combined with orlistat was determ