Table 3.
Dose Level, mg/kga | Estimated Mean Ratio AUC0–168h | 95% CI | P Value | Estimated Mean Ratio Cmax | 95% CI | P Value |
---|---|---|---|---|---|---|
IGF-1 | ||||||
0.02 mg/kg/Norditropin NordiFlex | 0.87 | [0.66, 1.13] | .2713 | 0.95 | [0.72, 1.24] | .6896 |
0.04 mg/kg/Norditropin NordiFlex | 1.08 | [0.82, 1.43] | .5719 | 1.13 | [0.85, 1.50] | .3940 |
0.08 mg/kg/Norditropin NordiFlex | 1.37 | [1.04, 1.82] | .0275 | 1.48 | [1.12, 1.97] | .0086 |
0.12 mg/kg/Norditropin NordiFlex | 2.32 | [1.77, 3.04] | <.0001 | 2.52 | [1.92, 3.32] | <.0001 |
IGFBP-3 | ||||||
0.02 mg/kg/Norditropin NordiFlex | 0.92 | [0.84, 1.01] | .0929 | 0.98 | [0.88, 1.09] | .6646 |
0.04 mg/kg/Norditropin NordiFlex | 1.01 | [0.91, 1.12] | .8380 | 1.03 | [0.92, 1.15] | .5697 |
0.08 mg/kg/Norditropin NordiFlex | 1.02 | [0.93, 1.13] | .6460 | 1.04 | [0.93, 1.16] | .5043 |
0.12 mg/kg/Norditropin NordiFlex | 1.19 | [1.08, 1.31] | .0010 | 1.19 | [1.06, 1.32] | .0031 |
Abbreviation: CI, confidence interval.
Assessments at dose 4 for NNC0195-0092 and at week 4/day 22 for Norditropin NordiFlex.