TABLE 5.
Parameter | Treatment (mg) | Comparison | Test |
Ref |
Ratio | 90% CI | ||
---|---|---|---|---|---|---|---|---|
No. of subjects | Geometric LS mean | No. of subjects | Geometric LS mean | |||||
AUC0–∞ (h · ng/ml) | 5 | Fed vs fasted | 5 | 1,348.60 | 6 | 1,428.33 | 0.94 | 0.71, 1.26 |
AUC0–t (h · ng/ml) | 5 | Fed vs fasted | 5 | 786.54 | 6 | 731.74 | 1.07 | 0.87, 1.34 |
Cmax (ng/ml) | 5 | Fed vs fasted | 5 | 46.98 | 6 | 48.42 | 0.97 | 0.76, 1.23 |
t1/2 (h) | 5 | Fed vs fasted | 5 | 34.35 | 6 | 38.64 | 0.89 | 0.64, 1.23 |
Tmax (h) | 5 | Fed vs fasted | 5 | 2.00 | 6 | 1.25 | 0.75b | −0.50, 2.50 |
CI, confidence interval; LS, least squares; Ref, reference.
Difference.