[Pharmacokinetics and bioequivalence of two peroral beclobrate preparations].

The pharmacokinetics of beclobrate (ethyl(+/-)-2-[[alpha-(p-chlorophenyl)-p-tolyl]-oxy]-2-methylbutyrate, SGD 24774), a new lipid lowering agent, and the bioequivalence of 50 and 100 mg capsules containing different amounts of excipient are presented. Both capsules are clinically investigated previously. In a cross over trial 18 healthy volunteers received 200 mg beclobrate p.o. The determination of beclobric acid (BS), the main metabolite of beclobrate in plasma was carried out by a HPLC method. The analytical method is described. Both capsules were bioequivalent. The mean values of maximal concentrations were about 4.5 micrograms/ml and they were reached approximately after 4 h. The AUCs were equal after both preparations, the mean bioequivalence factor was approximately 100. No significant differences in the kinetic parameters were found after both capsules, the mean elimination half life was 17.7 +/- 9.5 h after 100 mg capsules and 14.9 +/- 6.2 h after 50 mg capsules. The plasma clearance was equal with 35.0 ml/min. A simulation of the steady state plasma concentration was made. Both capsules, 50 and 100 mg respectively, were bioequivalent. For clinical application a dose regimen of once daily is indicated by the pharmacokinetic results.

RCT Entities:   Population Interventions Outcomes