Statistical Analyses
The main pharmacokinetic parameters of nifedipine, Cmax,
AUC0-t, and AUC0-∞, were log-transformed
and subjected to analysis of variance (ANOVA). The ANOVA model had
dosing order, formulation, and period as fixed effects, formulation
factors for different subjects as random effects, and the within-subject
formulation repeated measures (i.e., repeated doses of subject
formulation T, reference formulation R) effects were considered. The
within-subject standard deviation SWR, point estimates of the geometric
mean ratio, the upper limit of the 90% confidence interval, and the
one-sided 95% confidence interval of the geometric mean ratio (subject
formulation/reference formulation) were calculated for the main
indicators. The results of the double one-sided t-test are also
presented.