Comparative pharmacokinetics of 400 mg bezafibrate after a single oral administration of a new slow-release preparation and the currently available commercial form.
Bezafibrate is a new lipid-lowering agent with a more pronounced pharmacological effect, a different metabolism and a much shorter apparent half-life than clofibrate. The serum concentration curves and the urinary excretion were determined in seventeen healthy volunteers after administration of 400 mg of a new slow-release preparation. The results were compared with those of a similar experiment in twenty healthy volunteers who received 400 mg as a single dose in the form of 2 tablets of Cedur, which is the currently marketed form in Germany (each tablet contains 200 mg bezafibrate). The areas under the serum concentration curves were not statistically significantly different (median of 31.3 mg . h/l for the slow-release and of 39.4 mg . h/l for the marketed preparation). Renal clearance differed only within the margin of biological variation. It can be assumed that the relative biological availability of both preparations is similar. In none of the volunteers were subjective or objective side-effects observed.
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D001629:Bezafibrate; D002994:Clofibrate / Q000031:analogs & derivatives*; D002995:Clofibric Acid / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000097:blood / Q000378:metabolism / Q000652:urine; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D000960:Hypolipidemic Agents / Q000008:administration & dosage* / Q000378:metabolism*; D007700:Kinetics; D008297:Male
D003692:Delayed-Action Preparations; D000960:Hypolipidemic Agents; D002995:Clofibric Acid; D002994:Clofibrate; D001629:Bezafibrate