Pharmacokinetics and comparative bioavailability of two fenofibrate capsule formulations in healthy volunteers.
The objective of this study was to evaluate the pharmacokinetics of fenofibric acid, the main metabolite of fenofibrate (CAS 49562-28-9), and to assess the average bioequivalence of two immediate release formulations of 200 mg fenofibrate capsules in 24 healthy volunteers. The relative bioavailability of the test (generic) product Lipivim with respect to the reference product was determined in a single dose, randomized, crossover study. Only the concentrations of fenofibric acid could be used for bioequivalence determination, because the concentrations of the parent drug were too low to be accurately measured in the biological matrix. The mean values for the Cmax were 3.08 (+/- 1.69) microg/ml for the test and 3.05 (+/- 1.79) microg/ml for the reference product. The mean values for the AUC(0-infinity) were 94.5 (+/- 41.5) microg/ml h for the test and 88.2 (+/- 41.4) microg/ml h for thereference, respectively. The 90% confidence intervals for test/reference mean ratios of the plasma pharmacokinetic variables Cmax, AUC(0-t) and AUC(0-infinity) lie within the conventional bioequivalence range of 80-125% (Schuirman test). The difference between Tmax of the test and reference products was statistically non-significant (Friedman test). The test product is therefore bioequivalent to the reference product with respect to the rate and extent of fenofibric acid pharmacokinetics.
Department of Pharmaceutical Technology and Biopharmaceutics, Faculty of Pharmacy, University of Medicine and Pharmacy Iuliu Hatieganu, Cluj-Napoca, Romania. vlaselaur@yahoo.com
Laurian
L
Vlase
Adina
A
Popa
Dana
D
Muntean
Sorin E
SE
Leucuta
D000328:Adult; D019540:Area Under Curve; D002138:Calibration; D002214:Capsules; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D016568:Drugs, Generic; D011345:Fenofibrate / Q000493:pharmacokinetics*; D006801:Humans; D000960:Hypolipidemic Agents / Q000493:pharmacokinetics*; D016014:Linear Models; D008297:Male; D013056:Spectrophotometry, Ultraviolet; D013810:Therapeutic Equivalency; D055815:Young Adult
D002214:Capsules; D016568:Drugs, Generic; D000960:Hypolipidemic Agents; D011345:Fenofibrate