Table 2.
Parameter (Units) All mean ± SD | 54-mg fasting (n = 24) |
36-mg fasting (n = 22) |
18-mg fasting (n = 24) |
|||
---|---|---|---|---|---|---|
Sandoz MPH OCR | Concerta® | Sandoz MPH OCR | Concerta® | Sandoz MPH OCR | Concerta® | |
AUC0–t (ng.h/mL) | 116.70 ± 26.52 | 121.43 ± 27.00 | 89.37 ± 34.31 | 94.92 ± 32.85 | 39.89 ± 10.23 | 41.54 ± 9.90 |
AUC0–inf (ng.h/mL) | 121.98 ± 28.07 | 125.36 ± 28.12 | 95.72 ± 38.98 | 99.91 ± 36.19 | 41.52 ± 10.64 | 43.07 ± 10.58 |
Cmax (ng/mL) | 10.89 ± 2.09 | 12.11 ± 2.95 | 7.94 ± 2.79 | 8.39 ± 2.61 | 3.62 ± 0.81 | 3.76 ± 0.77 |
Tmax (h) | 5.81 ± 1.01 | 6.96 ± 1.56 | 5.70 ± 1.04 | 7.32 ± 1.49 | 5.65 ± 0.76 | 6.42 ± 1.49 |
Kel (h−1) | 0.1612 ± 0.0192 | 0.1811 ± 0.0199 | 0.1473 ± 0.0247 | 0.1634 ± 0.0211 | 0.1647 ± 0.0169 | 0.1781 ± 0.0200 |
T½ el (h) | 4.36 ± 0.55 | 3.88 ± 0.46 | 4.85 ± 0.93 | 4.32 ± 0.64 | 4.25 ± 0.43 | 3.94 ± 0.46 |
AUC0–2 h (ng.h/mL) | 6.59 ± 2.23 | 6.49 ± 2.18 | 4.93 ± 1.94 | 4.84 ± 1.51 | 2.26 ± 0.85 | 2.24 ± 0.83 |
AUC2–24 h (ng.h/mL) | 110.12 ± 24.85 | 114.93 ± 25.43 | 84.44 ± 32.96 | 90.08 ± 31.80 | 37.64 ± 9.64 | 39.29 ± 9.36 |
Cmax (0–2h) (ng/mL) | 5.43 ± 1.70 | 5.54 ± 1.86 | 4.00 ± 1.67 | 4.11 ± 1.24 | 1.88 ± 0.56 | 1.85 ± 0.57 |
Cmax (2–24h) (ng/mL) | 10.89 ± 2.09 | 12.11 ± 2.95 | 7.94 ± 2.79 | 8.39 ± 2.61 | 3.62 ± 0.81 | 3.76 ± 0.77 |