COMPARATIVE STEADY-STATE STUDY WITH 2 FENOFIBRATE 250-MG SLOW-RELEASECAPSULES - AN EXAMPLE OF BIOEQUIVALENCE ASSESSMENT WITH A HIGHLY VARIABLE DRUG

Twenty healthy male volunteers were treated with 2 different oral prep arations of fenofibrate according to a randomized 2-way crossover desi gn, The test preparation was Fenofibrate 250 mg retard capsules, batch No. YXF 001, provided by MTT Medical and Technological Transfer GmbH, Unterhaching, Germany. The reference preparation was Lipanthyl 250 mg retard capsules, batch No, R9110071, manufactured by Fournier Pharma, Sulzbach, Germany. On 12 consecutive days divided in 2 periods the vo lunteers received 6 doses of the test and reference formulation, respe ctively. The daily dose of 1 capsule contained 250 mg of fenofibrate a nd was administered together with a standardized high calory breakfast . Blood samples were taken immediately prior to each administration an d at 14 points after the last administration of each period. The conce ntration of the pharmacologically active compound, fenofibric acid, wa s determined by means of HPLC with UV detection. The calibration curve was linear in the range 0.1 - 20.0 mu g/ml (r=0.99997). A lower limit of quantification of 0.1 mu g/ml was established. The following mean values were obtained after administration of the test preparation: AUC (tau) 184.68 mu g/ml; C-max 13.11 mu g/ml; PTF: 125.0%. After administ ration of the reference formulation the following values were observed : AUC(tau) 175.91 mu gh/ml, C-max 12.27 mu g/ml, PTF: 120.0%, AUC(tau) , C-max and PTF were tested for bioequivalence parametrically after lo garithmic transformation, The preparations were found to be bioequival ent.