Table 1.
Dose-normalized AUC0–12h, dose-normalized Cmax, C0 and tmax for generic tacrolimus and reference tacrolimus
| Generic tacrolimus | Reference tacrolimus | p-Valuea | |
|---|---|---|---|
| Dose-normalized AUC0–12h (ng*h/mL) | 61.8 ± 40.6 | 60.0 ± 37.8 | 0.409 |
| Dose-normalized Cmax (ng/mL) | 9.6 ± 5.5 | 9.1 ± 5.5 | 0.199 |
| C0 (ng/mL) | 7.3 ± 1.8 | 7.0 ± 2.1 | 0.354 |
| Tmax (hours) | 1.5 ± 1.1 | 1.9 ± 1.3 | 0.073 |
Values are shown as mean ± SD of data obtained on days 14 and 28.
a
ANOVA model with fixed factors for treatment, period and sequence and a random factor for subject effect (nested within sequences).