生物学的同等性とバイオアベイラビリティのジャーナル

概要

Bioequivalence Evaluation of Two Brands of Ketoprofen 50 Mg Capsules (Flogofin®&Profenid®) In Healthy Latin American Volunteers

Baldo MN, Hunzicker GA, Altamirano JC, Murguía MC and Hein GJ

The study was performed to compare the bioavailability of two ketoprofen capsule (50 mg) formulations: Flogofin®, as test formulation, and Profenid®, as reference formulation. The study was conducted open with randomized two period crossover design and 1 week washout period in 24 fasting, healthy latino-american male volunteers and performed at the Biopharmaceutical Research Center Dominguez Lab. After dosing, serial blood samples were collected for a period of 24 h and plasma was separated and analyzed for ketoprofen, using a sensitive, reproducible, and accurate method by liquid chromatography – tandem mass spectrometry (LC-MS/MS). Pharmacokinetic parameters: AUC0-24, AUC0-∞, Cmax, Tmax, T1/2 and Ke, were analyzed from plasma concentrations of both formulations. The means AUC0-24 for test and reference formulation were 50.21 ([μg h]/mL) - 50.28 ([μgh]/mL), 52.38 ([μg h]/mL) - 50.84 ([μg h]/mL) for AUC0-∞, and 21.58 μg/mL - 21.65 μg/mL for Cmax, respectively. Statistical modules (ANOVA and 90% confidence intervals) were applied to AUC0–24, AUC0-∞, and Cmax to assess the bioequivalence of the two brands which revealed no significant difference between them, and 90% CI fell within the accepted bioequivalence range of 80%-125%. Based on these statistical inferences, both formulations were found to be bioequivalent.