Publication: Clinical Pharmacology in Drug Development
Abstract
This single-dose, randomized crossover study evaluated the pharmacokinetic bioequivalence of a generic budesonide nasal spray against the branded product (Rhinocort Aqua) in 32 healthy Chinese subjects under fasting conditions. Plasma budesonide was measured by LC-MS/MS and pharmacokinetic parameters calculated using Phoenix WinNonlin. The 90% confidence intervals for Cmax, AUC0-t, and AUC0-inf all fell within the standard 80-125% bioequivalence range, and the two products showed comparable safety profiles with no serious adverse events. The generic and branded budesonide nasal sprays were confirmed to be pharmacokinetically bioequivalent in this population.
Author(s): Li X, Li Y, Xu B, Zhang P, Wang Y, Wang Z, Hou S
Published: 2021 年 11 月 16 日
Phoenix WinNonlin: Bioequivalence for a Nasal Spray
Phoenix WinNonlin's pharmacokinetic analysis confirmed bioequivalence between a generic and branded budesonide nasal spray in this study. As part of a Phoenix platform accessible from any browser, on any device, Phoenix WinNonlin can be paired with AI PK Reports to turn an analysis into a complete PK document in minutes rather than days.
