Table 5.

Difference of ln-transformed PK variables between high-fat versus fasting condition (PP; n = 21) for Ciclosporin Pro and Sandimmun® Optoral

PK parameter	DCiclosporin Pro Mean [SD]	DCiclosporin Pro [95% CI]	Testing of H0*
			t-value	p-value**
AUCSS, τ	−0.1252 [0.2008]	[−0.2166; − 0.0338]	−2.86	0.0097
CSS, max	−0.3916 [0.4371]	[− 0.5906; − 0.1927]	−4.11	0.0005
CSS, min	− 0.0690 [0.2094]	[− 0.1644; 0.0263]	−1.51	0.1465
PK parameter	DSandimmun Optoral Mean [SD]	DSandimmun Optoral [95% CI]	Testing of H0*
			t-value	p-value**
AUCSS, τ	−0.1747 [0.1443]	[−0.2403; − 0.1090]	−5.55	<.0001
CSS, max	−0.5183 [0.3148]	[− 0.6616; − 0.3750]	−7.55	<.0001
CSS, min	− 0.0227 [0.1789]	[− 0.1041; 0.0588]	−0.58	0.5681

* Testing of H₀ (D_{Ciclosporin Pro} = 0) by means of the two-sided paired t-test

** lowest (two-sided) significance level, for which the null hypothesis could be rejected