Table 2. Summary of pharmacokinetic parameters of denosumab after single-dose subcutaneous administration (PK population).
| Parameter | Denosumab 60 mg (N = 23) |
Denosumab 120 mg (N = 23) |
|---|---|---|
| AUC(0-t) (day·μg/mL) | 319.3 (37.2) | 775.4 (23.2) |
| AUC(0-inf) (day·μg/mL) | 330.2 (39.3) | 813.5 (25.0) |
| AUC(0–16 weeks) (day·μg/mL) | 318.7 (36.8) | 752.3 (22.7) |
| Cmax (μg/mL) | 6.6 (34.4) | 14.1 (22.0) |
| Tmax (day) | 10.0 (1.0–27.2) | 10.0 (4.0–27.0) |
| t1/2 (day) | 14.7 (57.6) | 25.8 (29.1) |
| CL/F (mL/day) | 181.7 (39.3) | 147.5 (25.0) |
| Vd/F (mL) | 3845.9 (47.3) | 5495.9 (25.4) |
Note: Data are presented as geometric mean (CVb%) except for Tmax, where values are median (range).
AUC(0-t), area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration; AUC(0-inf), AUC from time zero to infinity; AUC(0–16 weeks), AUC from time zero to week 16; Cmax maximum plasma concentration; CL/F, apparent oral clearance; PK, pharmacokinetic; Tmax, time to reach Cmax; t1/2, terminal half-life; Vd/F, apparent volume of distribution.