Statistical analysis
Statistical analysis was performed by SAS 9.4. All data were tested by
two-side test and the probability value (P) less than 0.05 was
considered statistically significant.AUC and Cmax were
logarithmically transformed and analyzed by linear mixed effect model.
Sequence, period and formulation were fixed effects, and subject within
sequence was included as a random effect. Analysis of variance (ANOVA)
of cross-over design was performed on the log-transformed variables. The
geometric mean ratios (GMRs) of the primary pharmacokinetic parameters
and their 90% confidence intervals (CIs) were calculated, and the test
formulation was judged as bioequivalence if it fell within the
equivalent range (80-125%). Bioequivalence was assessed separately in
both the fasting and fed groups.