Publication: Clinical Pharmacology in Drug Development
Abstract
Potassium chloride sustained-release tablets are commonly used to treat potassium deficiency, but the interaction between dietary potassium intake and bioequivalence assessment for this endogenous substance was unclear. This publication reports two open-label, crossover bioequivalence studies of potassium chloride sustained-release tablets conducted under different dietary conditions in healthy Chinese volunteers, with urinary potassium measured by inductively coupled plasma-optical emission spectrometry and pharmacokinetic parameters analyzed using Phoenix WinNonlin. No significant differences in maximal or cumulative urinary potassium excretion were observed between test and reference formulations under either dietary condition. The bioequivalence of both potassium chloride sustained-release tablet formulations was successfully established regardless of dietary arrangement.
Author(s): Li Q, Yang Z, Liu SJ, Liu L, Chen L, Zhang Q, Zhou Y, Du P, Zeng C, Li N, Zeng Y, Xiong Y, Liu DJ, Chen J, He Y
Published: November 2, 2022
Phoenix WinNonlin: Bioequivalence for an Endogenous Substance
Phoenix WinNonlin’s pharmacokinetic analysis supported this potassium chloride bioequivalence study across different dietary conditions. Paired with AI PK Reports, Phoenix WinNonlin can help turn an analysis into a complete PK document in minutes rather than days, within a Phoenix platform trusted by scientists and regulators for over three decades.
