Comparative Bioequivalence Study of 2 Fixed Dose Combinations of Ibuprofen at a Tabet Strength of 400 mg in Moroccan Volunteers
Author(s): Salma Lazrak*, Choukri El Khabbaz, Inass Moufarraj, Mehdi Eddarai, Miloud El Karbane, Yahia Cherrah
Abstract
This study compared ALGANTIL® 400 mg film-coated tablets, used as the test product, with BRUFEN® 400 mg film-coated tablets, used as the reference product, in healthy Moroccan volunteers. Twenty-four subjects received a single dose of each formulation in a randomized, single-blind, two-sequence, two-period crossover study conducted after an overnight fast. All randomized subjects completed both periods. Ibuprofen exposure was characterized from serial plasma concentrations. The pharmacokinetic evaluation included Cmax, AUC?–t, AUC?–∞, Tmax, and t?/?. Blood was collected according to a pre-specified sampling schedule after each treatment, and ibuprofen was quantified in plasma by a validated LC–MS/MS assay meeting the applicable bioanalytical validation requirements. Systemic exposure was similar after administration of the two products. The 90% confidence intervals for the test/reference geometric mean ratios of Cmax, AUC?–t, and AUC?–∞ were all contained within the predefined bioequivalence interval of 80%–125%. No adverse event, serious adverse event, or withdrawal related to safety occurred during the study, and both formulations were well tolerated. Accordingly, the pharmacokinetic comparison under fasting conditions established bioequivalence between ALGANTIL® 400 mg and BRUFEN® 400 mg film-coated tablets, indicating comparable ibuprofen exposure after a single oral dose.