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Table 3 AUCSS, τ [h*ng/ml], CSS, max [ng/ml], and CSS, min [ng/ml] for each treatment and nutrition condition (PP; n = 21)

From: Randomized, open-label, comparative phase IV study on the bioavailability of Ciclosporin Pro (Teva) versus Sandimmun® Optoral (Novartis) under fasting versus fed conditions in patients with stable renal transplants

 

Ciclosporin Pro

Sandimmun Optoral

fasting

high-fat

fasting

high-fat

Geom. mean

95% CI

CV %

Geom. mean

95% CI

CV %

Geom. mean

95% CI

CV %

Geom. mean

95% CI

CV %

AUC

3006.5

[2652.7;3407.5]

28.0

2652.7

[2334.5;3014.2]

28.6

3228.6

[2857.8;3647.6]

27.3

2711.2

[2357.7;3117.7]

31.4

Cmax

844.6

[702.4;1015.7]

42.2

570.9

[463.6;703.2]

48.3

940.6

[802.7;1102.3]

35.9

560.2

[454.3;690.8]

48.6

Cmin

97.9

[87.1;110.1]

26.2

91.4

[81.1;103.0]

26.7

100.0

[88.8;112.5]

26.4

97.7

[86.9;109.9]

26.2