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Name | Bioequivalence and Pharmacokinetic Evaluation of Two Formulations of Fenofibrate 145 Mg in Healthy Indian Subjects |
Description | Original research article:-Shep Dhaneshwar1, Ojha Ashwini 2, Patel Sweta3, Nivsarkar Manish4, *Jaiswal Vijaya5 and Padh Harish6 1.Sr. Manager, Medical Services, Troikaa Pharmaceuticals Ltd., Ahmedabad, India. 2.Scientist A, Department of Bio-analytical, B.V. Patel PERD Centre, Ahmedabad, India 3.Research Assistant, Department of Biostatistics, B.V. Patel PERD Centre, Ahmedabad,India. 4.Joint Director, Department of Pharmacology and Toxicology, B.V. Patel PERD Centre, Ahmedabad, India. 5.Vice-President, Medical Services, Troikaa Pharmaceuticals Ltd, Ahmedabad, India. 6.Vice chancellor, Sardar Patel University, Vallabh Vidyanagar, India.
Abstract:-The prodrug fenofibrate, a synthetic phenoxy-isobutyric acid derivative, is rapidly hydrolyzed in vivo to form fenofibric acid, which alters plasma lipid levels by activating the peroxisome proliferator-activated receptor alpha. The aim of this study was to compare the bioavailability and tolerability of 2 oral formulations of fenofibrate 145 mg. The study was designed as a single-dose, randomized, single-label, 2-period crossover study in healthy Indian adult volunteers. Subjects received 1 tablet of each fenofibrate 145 mg formulation. Study drugs were administered with 240 mL of water after standardized meal on each of 2 treatment days separated by a 2-week washout period. After study drug administration, serial blood samples were collected over a period of 96 hours. Plasma was analyzed for fenofibric acid concentration using a validated high-performance liquid chromatography method. Pharmacokinetic (PK) parameters Cmax, Tmax, t1/2, AUC0-t, AUC 0-∞, and kel, were determined for the 2 fenofibrate formulations. The formulations were to be considered bioequivalent if the log-transformed ratios of Cmax, AUC0-t, and AUC0-∞ were within the predetermined bioequivalence range of 80% to 125%. A total of 18 subjects were enrolled. No significant differences were found based on analysis of variance, with mean values and 90% confidence intervals of test/reference ratios for these parameters as follows: Cmax, 6.40 versus 7.12 μg/mL (81.71 – 103.05); AUC0-t, 139.57 versus 153.50 μg.hr/mL (85.56 – 102.02); and AUC0-∞, 147.49 versus 161.25 μg.hr/mL (83.44 – 105.87). In these healthy adult Indian volunteers, results from the PK analysis suggested that the test and reference formulations of fenofibrate 145 mg tablets were bioequivalent. Both the formulations were well tolerated.
Key words :- Bioequivalence, Fenofibrate, Pharmacokinetics. |
Filename | Dhaneshwar S et.al..pdf |
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Created On: | 06/17/2011 00:00 |
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Last updated on | 07/22/2011 12:17 |
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