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

Table 6 Ratio of non-transformed PK variables of Ciclosporin Pro to Sandimmun® Optoral under fasting condition (top) and under high-fat conditions (bottom) (PP; n = 18)

	Bioavailability_{Ciclo Pro}/Bioavailability_Optoral Geometric mean	Bioavailability_{Ciclo Pro}/Bioavailability_Optoral [90% CI]
PK parameter (fasting)
AUC_{SS, τ}	0.940	[0.868; 1.018] ^a
C_{SS, max}	0.863	[0.745; 0.999]
C_{SS, min}	1.011	[0.922; 1.108] ^b
PK parameter (high-fat)
AUC_{SS, τ}	1.034	[0.972; 1.099] ^b
C_{SS, max}	1.082	[0.930; 1.260]
C_{SS, min}	0.955	[0.881; 1.035] ^a

ISSN: 1471-2369