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Comparative Pharmacokinetics of Two Extended-Release Tablet Formulations of Upadacitinib: Bioequivalence Assessment
Biao Sun1, Li Zhao2, Fangliang Gan3
1Department of Pharmacy, Xianning Central Hospital, The First Affiliated Hospital of Hubei University of Science and Technology, Xianning, P. R. China.
Abstract:
The aim of this study is to evaluate the pharmacokinetic characteristics, bioequivalence, and safety of two brands of upadacitinib (UPA) extended-release tablets (15 mg) in healthy Chinese subjects under fasting and postprandial conditions. The plasma concentration of UPA was determined by ultra-high-performance liquid chromatography-tandem mass spectrometry, and pharmacokinetic parameters were calculated using a non-compartmental model (NCA module) with Phoenix WinNonlin 8.2 (Certara, USA) software, followed by bioequivalence evaluation. The results demonstrate that the 90% confidence intervals for the geometric least-squares mean ratios of Cmax, AUC0-t, and AUC0-∞ between the test and reference formulations fall within the range of 0.80-1.25, indicating that both formulations are bioequivalent in terms of absorption rate and extent under fasting and postprandial conditions. No serious adverse events occurred, and observed drug-related adverse events were mild under both conditions, indicating comparable safety of the two formulations.
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