PK parameters (unit) | GLSM and ratio | CV (%) | 90%CI | Power (%) | ||
---|---|---|---|---|---|---|
Test product | Reference product | T/R(%) | ||||
(N) | (N) | |||||
Cmax (ng/mL) | 45.9571 (39) | 45.7018 (40) | 100.56 | 18.58 | (93.73,107.88) | > 99.9 |
AUC0-t (h*ng/mL) | 144.6536 (39) | 146.6111 (40) | 98.66 | 10.09 | (94.95,102.53) | > 99.9 |
AUC0-∞ (h*ng/mL) | 148.9203 (39) | 150.6285 (40) | 98.87 | 10.45 | (95.01,102.88) | > 99.9 |