Hunzicker GA
Argentina
Research Article
Bioequivalence Evaluation of Two Brands of Ketoprofen 50 Mg Capsules
(Flogofin®&Profenid®) In Healthy Latin American Volunteers
Author(s): Baldo MN, Hunzicker GA, Altamirano JC, Murguía MC and Hein GJBaldo 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), .. View More»
DOI:
10.4172/jbb.1000223