Comparative Bioequivalence and Safety Evaluation of Ibuprofen/Phenylephrine Hydrochloride Fixed-Dose Combination...

This single-center, randomized, open-label bioequivalence program compared two fixed-dose combination (FDC) tablets containing ibuprofen (200 mg) and phenylephrine hydrochloride (10 mg) from different manufacturers in healthy Chinese adults under fasting and fed conditions. A three-period, partially replicated crossover design was used for the fasting study and a four-period, fully replicated crossover design for the fed study. Serial plasma samples were collected up to 16 h post-dose, and pharmacokinetic parameters included C_max, AUC_0-t, and AUC_0-∞ for both analytes. Bioequivalence was assessed using average bioequivalence (ABE) when the within-subject standard deviation of the reference was <0.294 and reference-scaled ABE (RSABE) otherwise. The geometric mean ratios (90% CIs) for C_max, AUC_0-t, and AUC_0-∞ of both ibuprofen and phenylephrine fell within 80%-125% in both nutritional states, with RSABE applied to phenylephrine C_max where variability was high. Both products were well tolerated; adverse events were mild, comparable between test and reference, and no subject discontinued due to adverse events. These findings demonstrate bioequivalence of the two ibuprofen/phenylephrine FDC and support their similar safety profiles in healthy Chinese volunteers.