Pharmacokinetics, Relative Bioavailability, and Safety of the SHR0302 Oral Solution and Tablets: A Single-Center, Randomized, Open-Label, Crossover (Two-Formulation, Two-Period) Phase I Trial in Healthy Chinese Volunteers

This Phase I study evaluated the pharmacokinetics, relative bioavailability, and safety of SHR0302 oral solution compared with tablet formulations in 16 healthy Chinese male volunteers, using a single-center, randomized, open-label, two-formulation, two-period crossover design. Plasma concentrations were measured by LC-MS/MS, and pharmacokinetic parameters were derived by non-compartmental analysis using Phoenix WinNonlin. The geometric mean ratios for Cmax and both AUC measures between the oral solution and tablet formulations fell entirely within the standard 80-125% bioequivalence range, and only mild treatment-emergent adverse events were reported, with no serious events. The findings demonstrate that the SHR0302 oral solution offers bioavailability comparable to the tablet formulation with a favorable safety profile.