2.7 Statistical analysis

Phoenix WinNonlin Software v8.0, was used to calculate the PK parameters using the non-compartmental method, and individual plasma concentration–time curves were constructed. The main PK parameters derived from the plasma concentration–time curve were subjected, after logarithmic transformation, to multivariate analysis of variance that included participants nested within the sequence as a random effect and sequence, formulation, and period as fixed effects. Two-sided t-tests were performed. Statistical analysis of the T_max was performed using the non-parametric Wilcoxon two-sample test. Descriptive statistics were used for the PK parameters, and count or grade data were expressed as frequencies and percentages. Statistical analyses were performed using the statistical software package SAS, V9.4. p < 0.05 was considered statistically significant.