Study of dose-linearity of gemfibrozil pharmacokinetics in human

Abstract

To study the dose linearity of gemfibrozil in therapeutic range, the pharmacokinetic of gemfibrozil was assessed in twelve healthy volunteers after administration of single oral does of 300, 600 and 900 mg gemfibrozil in a randomized cross-over design. Serial blood samples were collected at predetermined times before and after drug administration. Serum gemfibrozil concentrations were determined by a validated reversed phase HPLC method. Pharmacokinetic parameters determined by non compartmental methods. The mean elimination half-lives (t1/2) of gemfibrozil, which did not vary with the dose, were 1.3±0.2, 1.2±0.2 and 1.4±0.1 h, respectively after the three administered doses. The peak serum levels (Cmax) and area under the serum level versus time curve (AUC) data showed dose-proportional response. The time to peak serum concentration (tmax), apparent clearance (CL/F) and apparent volume of distribution (Vd/F) did not show significant difference over the administered doses. These findings suggest that gemfibrozil disposition is linear over the dose range studied. © 2006 Asian Network for Scientific Information.