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Abstract

Bioequivalence Of Fenofibrate Tablet Formulations In Healthy Indian Male Subjects

Author(s): Shubha Rani, M Nivsarkar, Rajeshwari Rathod, Swati Guttikar, H Padh

Fenofibrate is among the drugs of choice for treatment of hypertriglyceridemia and low levels of high-density lipoprotein. Its metabolite fenofibric acid is responsible for the pharmacodynamic effects of the drug. Two fenofibrate formulations were investigated in 18 healthy, Indian, male volunteers to demonstrate bioequivalence between these formulations. A single dose of 160 mg was given to volunteers in a two way randomized fashion with a wash out period of fourteen days. Blood samples were collected till 96 h following drug administration. Fenofibric acid concentrations were determined using a validated HPLC method using UV detector at wavelength of 287 nm. Additionally in vitro tests were performed using both the formulations to see the dissolution characteristics. The mean peak plasma concentration for the fenofibric acid (Cmax) as 5.52 and 5.35 μg/ml for test and reference formulations. The Cmax was achieved at 3.39 (test formulation) and 3.00 (reference formulation) h. The area under the plasma-concentration-time-curve AUC0-t and AUC0-âˆÅ¾ had mean values of 135.1 and 156.4 μg.h/ml for the test formulation and 124.9 and 139.6 μg.h/ml for reference formulation. The resulting 90% confidence intervals of the parameter ratios were (85.0, 112.1) for Cmax, (8 9.1, 117.5) for AUC0-t and (90.3, 119.4) for AUC0-âˆÅ¾. Though the bioequivalence criteria were met, test formulation showed a little higher value of all the considered pharmacokinetic parameters. Interestingly, this difference correlated well with the observation of more dissolution from the test formulation.