Table 2.
Summary of PK End Points for NNC0195-0092 and Norditropin NordiFlex
| Dose, mg/kg | n | AUC0-τ, ngh/mL | Cmax, ng/mL | tmax, h | RAcc |
|---|---|---|---|---|---|
| NNC0195-0092 | |||||
| After first dose | |||||
| 0.02 | 7 | 475 (94.5) | 14.4 (119.5) | 11.1 (7.8) | |
| 0.04 | 6 | 777 (71.3) | 19.8 (115.0) | 25.6 (35.8) | |
| 0.08 | 6 | 2753 (173.6) | 64.2 (193.1) | 16.6 (11.0) | |
| 0.12 | 7 | 6382 (71.6) | 142.5 (129.1) | 22.5 (11.0) | |
| After fourth dose | |||||
| 0.02 | 7 | 666 (70.9) | 14.4 (193.2) | 9.0 (10.6) | 2.0 (2.0) |
| 0.04 | 6 | 986 (93.3) | 20.6 (201.2) | 5.4 (4.6) | 1.3 (0.3) |
| 0.08 | 6 | 2085 (102.2) | 45.4 (127.6) | 15.2 (15.8) | 1.3 (0.6) |
| 0.12 | 7 | 5431 (61.7) | 114.8 (113.3) | 17.2 (12.0) | 1.0 (0.2) |
| Norditropin NordiFlex | |||||
| Norditropin NordiFlex, wk 1/d 1) | 8 | 21 (202.1) | 1.6 (195.7) | 3.8 (5.0) | |
| Norditropin NordiFlex, wk 4/d 22) | 8 | 17 (153.4) | 1.5 (185.1) | 5.3 (6.3) | 0.9 (0.3) |
Abbreviation: AUC0-τ, AUC from 0 hour to next dosing Data are presented as mean (SD). Area under the serum concentration-time curve from time zero to time (AUCτ) and Cmax are presented as geometric mean (CV percentage). The RAcc was calculated as mean (SD) = AUC(0–168 h, dose 4)/AUC(0–168 h, dose 1). For Norditropin NordiFlex, the RAcc was calculated for AUC0-τ, week 4, day 22 per AUC0-τ, week 1, day 1.