Bioequivalence Study of Two Ibuprofen Arginine Formulations in Healthy Chinese Subjects Under Fed Conditions.

Authors

Yiyang Ying, Chunqi Huang, Li Xu, Yi Wu, Shufan Cai, Lijun Ye, Xiangxin Huang, Lin Wang, Ying Wang

Published in

Clinical pharmacology in drug development. Volume 15. Issue 8. Pages e70083.

Abstract

To evaluate the bioequivalence and safety of a generic ibuprofen arginine formulation (T) compared to Sibide (R) in healthy Chinese subjects under fed conditions, a randomized, open-label, single-dose, two-period, two-sequence crossover study was conducted. Twenty-eight eligible healthy subjects received a single 400 mg dose of either the T or R formulation following a standardized high-fat meal, with a 3-day washout period between doses. Plasma ibuprofen concentrations were quantified using a validated LC-MS/MS method. Pharmacokinetic parameters, including C_max, AUC_0-t, and AUC_0-∞, were calculated using non-compartmental analysis. Bioequivalence was assessed based on the geometric mean ratios (GMRs) and 90% confidence intervals (CIs) derived from ANOVA. All 28 enrolled subjects completed the study. The GMRs (90% CIs) for C_max, AUC_0-t, and AUC_0-∞ were 107.03% (100.02%-114.52%), 100.99% (98.46%-103.58%), and 100.95% (98.24%-103.74%), respectively. All 90% CIs fell entirely within the regulatory bioequivalence acceptance range of 0.80-1.25. Both formulations were well tolerated; adverse events were mild to moderate, and no serious adverse events were reported. Thus, the T formulation of ibuprofen arginine demonstrated bioequivalence to the R formulation in healthy Chinese subjects under fed conditions.

PMID:
42605530
Bibliographic data and abstract were imported from PubMed on 17 Aug 2026.

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