Publication: Clinical Pharmacology in Drug Development
Abstract
This study characterizes the pharmacokinetics and bioequivalence of sildenafil citrate orally disintegrating tablets compared with a reference formulation in 38 healthy Chinese subjects under fasting conditions. Using a randomized, two-sequence, two-period crossover design, plasma concentrations of sildenafil and its active metabolite N-desmethyl sildenafil were quantified by HPLC-MS/MS, and pharmacokinetic parameters were derived by non-compartmental analysis with Phoenix WinNonlin. The 90% confidence intervals for the geometric mean ratios of Cmax, AUC0-t, and AUC0-inf all fell within the standard 80-125% bioequivalence range for both sildenafil and its metabolite. The results confirm that the orally disintegrating tablet formulation is bioequivalent to the reference product with respect to rate and extent of absorption.
Author(s): Zhang Y, Du L, Liu S, Chen G, Han H, Huang J, Jiang H, Wang X, Guo D, Gan F
Published: 2026 年 3 月 1 日
Phoenix WinNonlin: Parent and Metabolite PK
Phoenix WinNonlin calculated pharmacokinetic parameters for both sildenafil and its active metabolite in this bioequivalence study, supporting a full picture of drug and metabolite exposure. As part of a Phoenix platform cited in more than 33,000 peer-reviewed articles, Phoenix WinNonlin remains the gold standard engine for noncompartmental analysis, PK/PD, and toxicokinetic modeling.
