Table 3 Pharmokinetic parameters
Parameter | IR-cysteamine (Cystagon®) | DR-cysteamine (Procysbi®) | p-value |
|---|---|---|---|
Mean minimum concentration of cystine (in nmol cystine/mg protein) | 0.38 ± 0.3 | 0.41 ± 0.41 | 0.59 |
Mean Cmax of cysteamine (in µmol/l) | 72.58 ± 46.45 | 56.2 ± 28.3 | 0.28 |
Mean Tmax of cysteamine (in minutes) | 75.0 ± 24.5 | 159.38 ± 39.07 | 0.001 |
Time with cystine values under 0.5 (in minutes) | 196.46 | 216.71 | 0.55 |
AUC cysteamine (after 1 dosing) | 9400.8 | 11,578.8 | |
AUC cysteamine (24 h) | 37,603.2 | 23,157.6 |