Table 4.
PK parameter | DCiclosporin Pro – DSandimmun Optoral Mean [SD] | DCiclosporin Pro – DSandimmun Optoral [97.5% CI] | Testing of H0* | |
---|---|---|---|---|
t-value | p-value** | |||
CSS, max | 0.1266 [0.6248] | [−0.1578; Infinity] | 0.93 | 0.1820 |
AUCSS, τ | 0.0494 [0.2850] | [−0.0803; Infinity] | 0.79 | 0.2180 |
CSS, min | −0.0464 [0.3271] | [−0.1953; Infinity] | − 0.65 | 0.7384 |
Bold entries are significant
* Testing of H0 (0 ≥ DCiclosporin Pro - DSandimmun Optoral) by means of the one-sided paired t-test (α = 0.025)
** lowest (one-sided) significance level, for which the null hypothesis could be rejected