Comparative Bioequivalence and Safety Evaluation of Ibuprofen/Phenylephrine Hydrochloride Fixed-Dose Combination Tablets in Healthy Chinese Volunteers.

ABSTRACT: 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

SUBMITTER: Ye M 

PROVIDER: S-EPMC12946568 | biostudies-literature | 2026 Mar

REPOSITORIES: biostudies-literature