TABLE 5.
PK parameter | GM and GMR | IIV% | 90%CI | ||
---|---|---|---|---|---|
T (N = 71) | R (N = 71) | GMR (%) | |||
Cmax (ng/ml) | 3.759 | 3.656 | 102.89 | 52.89 | 89.54–118.23 |
AUC0–t (h ng/ml) | 4.762 | 4.614 | 103.41 | 12.45 | 99.88–107.07 |
AUC0–∞ (h ng/ml) | 4.838 | 4.696 | 103.25 | 12.94 | 99.59–107.05 |
GMR refers to the geometric mean ratio of the test over reference pharmacokinetic metric. IIV refers to the intraindividual variation.