Salma Lazrak
Center for Bioequivalence, Studies of the Sheikh Zaid Foundation, MoroccoPublications
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Research Article
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, El Mehdi Eddarai, Miloud El Karbane and Yahia Cherrah
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% confiden.. Read More»
DOI: 10.4303/JDAR/236528