1. Pharmacokinetics, Bioequivalence, and Safety Evaluation of Two Formulations of 0.2-g Ibuprofen Granules
- Author
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Jianfen Su, Canhua Zhang, Yue Su, Chen Huang, Jinlong Zhao, Hui Yang, Zuoheng Xu, Jianhao Li, and Xinchun Yang
- Subjects
Pharmaceutical Science ,Pharmacology (medical) - Abstract
Ibuprofen is a nonsteroidal anti-inflammatory agent. In this study, we compared the pharmacokinetic properties, bioequivalence, and safety of a newly developed generic formulation (test) and a branded formulation (reference) of 0.2 g ibuprofen granules in healthy Chinese participants in fasting and fed arms. The randomized, single-dose, open-label, two-preparation, two-sequence, two-period crossover study had a washout period of 7 days between each period. It was conducted in 72 participants, 24 in the fasting arm and 48 in the fed arm. The concentration of ibuprofen in the plasma was determined using high-performance liquid chromatography-tandem mass spectroscopy. The primary pharmacokinetic parameters were calculated using a noncompartmental model. Safety assessments were performed throughout the study. The mean values of C
- Published
- 2022