Publication: Clinical Pharmacology in Drug Development
Abstract
This publication reports a bioequivalence assessment of two extended-release tablet formulations of upadacitinib (15 mg) in healthy Chinese subjects under both fasting and postprandial conditions. Plasma concentrations were measured using ultra-high-performance liquid chromatography-tandem mass spectrometry, and pharmacokinetic parameters were derived through non-compartmental analysis with Phoenix WinNonlin. The 90% confidence intervals for the geometric least-squares mean ratios of Cmax, AUC0-t, and AUC0-inf between the test and reference formulations fell entirely within the standard 0.80-1.25 bioequivalence range under both conditions. Adverse events were mild and comparable between formulations, with no serious events reported. The study supports bioequivalence and comparable safety of the two upadacitinib formulations.
Author(s): Sun B, Zhao L, Gan F, Zhan Q
Published: 2026 年 6 月 1 日
Phoenix NLME：Practical Population PK
Phoenix NLME supports the modeling behind bioequivalence and exposure studies like this upadacitinib comparison. A study like this one can be run with Phoenix NLME, quickly and to a standard regulators recognize. Phoenix NLME is the engine behind population PK/PD modeling, combining the flexibility of code with the ease of a guided interface, part of a Phoenix platform trusted by scientists and regulators for over three decades.
