Comparative bioéquivalence study of 2 fixed dose combinations of Ibuprofen at a tabet strength of 400 mg in Moroccan volunteers

This study aimed to evaluate the bioequivalence between the test product, ALGANTIL® 400 mg film-coated tablets, and the reference product, BRUFEN® 400 mg film-coated tablets, in healthy Moroccan volunteers. A single-dose, randomized, single-blind, 2-sequence, 2-period crossover study design was conducted under fasting conditions in 24 participants, all of whom completed the study. The test formulation was compared with the reference formulation by assessing key pharmacokinetic parameters, including maximum plasma concentration (Cmax), area under the concentration–time curve from time zero to the last measurable concentration (AUC₀–t), area under the concentration–time curve extrapolated to infinity (AUC₀–∞), time to reach maximum concentration (Tmax), and elimination half-life (t₁/₂). Blood samples were collected at predefined time points following drug administration, and plasma concentrations of ibuprofen were determined using a validated liquid chromatography–tandem mass spectrometry (LC–MS/MS) method in accordance with regulatory guidelines. Pharmacokinetic analysis demonstrated comparable results between the test and reference formulations. The 90% confidence intervals for the geometric mean ratios of Cmax, AUC₀–t, and AUC₀–∞ were within the predefined bioequivalence acceptance range of 80%–125%. Safety evaluation indicated that both formulations were well tolerated. No adverse events or serious adverse events were reported, and no subject discontinued participation due to safety concerns. In conclusion, ALGANTIL® 400 mg film-coated tablets can be considered bioequivalent to BRUFEN® 400 mg film-coated tablets under fasting conditions. These results support the therapeutic equivalence and interchangeability of the test product with the reference product.