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

D_{Ciclosporin Pro}

Mean [SD]

D_{Ciclosporin Pro}

[95% CI]

t-value

p-value^**

AUC_{SS, τ}

−0.1252 [0.2008]

[−0.2166; − 0.0338]

−2.86

0.0097

C_{SS, max}

−0.3916 [0.4371]

[− 0.5906; − 0.1927]

−4.11

0.0005

C_{SS, min}

− 0.0690 [0.2094]

[− 0.1644; 0.0263]

−1.51

0.1465

PK parameter

D_{Sandimmun Optoral}

Mean [SD]

D_{Sandimmun Optoral}

[95% CI]

t-value

p-value^**

AUC_{SS, τ}

−0.1747 [0.1443]

[−0.2403; − 0.1090]

−5.55

<.0001

C_{SS, max}

−0.5183 [0.3148]

[− 0.6616; − 0.3750]

−7.55

<.0001

C_{SS, min}

− 0.0227 [0.1789]

[− 0.1041; 0.0588]

−0.58

0.5681