TABLE 6.
PK parameter | GM and GMR | IIV% | 90%CI | ||
---|---|---|---|---|---|
T (N = 71) | R (N = 72) | GMR (%) | |||
Cmax (ng/ml) | 3.759 | 3.656 | 102.86 | 52.89 | 89.59–118.11 |
AUC0–t (h ng/ml) | 4.762 | 4.614 | 103.39 | 12.45 | 99.86–107.03 |
AUC0–∞ (h ng/ml) | 4.838 | 4.696 | 103.22 | 12.94 | 99.57–107.01 |
GMR refers to the geometric mean ratio of the test over reference pharmacokinetic metric. IIV refers to the intraindividual variation.