BACKGROUND: A novel @entity5018 ( @entity12690 ) formulation, Advil(  ) Film-Coated Tablets (IBUNa), was developed. OBJECTIVE: Pharmacokinetic comparison of IBUNa versus other @entity12690 formulations. STUDY DESIGN: Two randomized, single-dose, open-label, five-way crossover pharmacokinetic studies. SETTING: Inpatient research clinic. SUBJECTS: Seventy-one healthy adult volunteers. INTERVENTION: Study 1: In three periods, fasted subjects received 400-mg @entity12690 dose equivalents as IBUNa 2  *  256  mg, Advil(  ) Liqui-Gels(  ) (IBULG) 2  *  200  mg, and Motrin(  ) IB (IBUMot) 2  *  200  mg tablets. In two periods following a high-fat breakfast, subjects received 400-mg @entity12690 dose equivalents as IBUNa 2  *  256  mg and IBULG 2  *  200  mg. Study 2: In five study periods, fasted subjects received 400-mg @entity12690 dose equivalents as IBUNa 2  *  256  mg, Advil(  ) FastGel(  ) (IBUFG) 2  *  200  mg, @entity68325 (  ) (IBUNur) 2  *  200  mg, @entity68325 (  ) (IBUAdv) 2  *  200  mg, and @entity68325 (  ) Express containing @entity12690 lysinate (IBULys) 2  *  342  mg. MAIN OUTCOME MEASURE: Log-transformed area under the plasma concentration versus time curve to last observable concentration (AUCL) and maximum plasma concentration (C max) were the primary pharmacokinetic parameters; time to maximum measured plasma concentration (T max) was analyzed post hoc. RESULTS: IBUNa was bioequivalent to IBULG (fasted and fed) and IBUFG and IBULys (fasted) for rate (C max) and extent (AUCL) of @entity12690 absorption. After fasting, AUCL was bioequivalent for IBUNa and IBUMot, IBUAdv, and IBUNur, but C max occurred significantly earlier with IBUNa. After fasting, median IBUNa T max was comparable to that for IBULG, IBUFG, and IBULys, but was much shorter than that for IBUMot, IBUNur, and IBUAdv. Food slowed absorption of IBUNa and IBULG similarly. All treatments were tolerated similarly. CONCLUSION: IBUNa is absorbed faster but to a similar extent as standard @entity12690 formulations.

Ibuprofen sodium is absorbed faster than standard XXXX tablets: results of two open-label, randomized, crossover pharmacokinetic studies.

@entity5018 :: ('MESH:D007052', 'Chemical') :: ['ibuprofen'] @entity12690 :: ('CHEBI:30356', 'Chemical') :: ['IBU'] @entity68325 :: ('CHEBI:5855', 'Chemical') :: ['Nurofen', 'Advil']
@entity5018 :: (MESH:D007052,Chemical) :: ['Ibuprofen']
