Pharmacokinetic and pharmacodynamic analysis
PD
The sample size was determined based on the Chinese regulatory requirement for a phase I study. A total of 64 volunteers were enrolled in this study. The safety population included volunteers who had received at least one dose of the study treatment; the PK and PD population included volunteers who had received at least one dose of the study treatment and for whom PK and PD samples were obtained and analysed.The PK parameters were calculated with WinNonlin 8.3.1 (Certara, Princeton, NJ, USA) using non-compartmental analysis, including To examine dose proportionality, a power model, log (parameter) = α + β × log(dose), where α and β are constants, was fitted to the data. The slope (β), with its corresponding 90% confidence interval (CIs), was estimated to assess the degree of dose proportionality. A β value of 1 indicates linear PKs.In the food effect study, The PD parameters of 