Relative Bioavailability of Single-Dose Oral Administration of Two SHR7280 Formulations (Dry Suspension and Tablets) in Healthy Chinese Volunteers

SHR7280 is an oral small-molecule GnRH antagonist in development for hormone-dependent cancers, and a dry suspension formulation is being explored to serve patients who cannot swallow solid dosage forms. This study evaluated the relative bioavailability, pharmacokinetics, and safety of a single 200-mg dose of SHR7280 as dry suspension versus tablets in 16 healthy Chinese volunteers, using a randomized, open, two-preparation, double-crossover design with plasma concentrations measured by LC-MS/MS and pharmacokinetic parameters calculated in Phoenix WinNonlin. The geometric mean ratios for Cmax and both AUC measures between the two formulations fell largely within standard bioequivalence bounds, indicating comparable bioavailability, and treatment-emergent adverse events occurred in just over half of participants with a favorable overall safety profile. The findings support the dry suspension as a viable alternative administration route for SHR7280 with bioavailability comparable to the tablet form.