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. 2015 Jan 5;3(1):e00072. doi: 10.1002/prp2.72

Table 2.

Descriptive statistics of pharmacokinetic parameters for Sandoz MPH OCR and Concerta® in the fasting studies.

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