Table 1.
Pharmacokinetic characterization of denosumab is based on 73 healthy male and female subjects (age 18–64 years) and meta-analysis of seven Phase I studies, two Phase II studies, and two Phase III studies (n=1,564)
| Pharmacokinetic parameter | |
| Cmax | 6.75 ± 1.89 μg/mL |
| Tmax | 10 (range 3–21) days |
| Mean half-life (SD) | 25.4 ± 8.5 days |
| Mean AUC0–16 weeks (SD) | 316 ± 101 μg*day/mL |
| Subcutaneous bioavailability | 64% |
| ka | 0.00883 per hour |
| Central volume of distribution | 2.49 L/66 kg |
| Linear clearance | 3.06 mL/hour/66 kg |
| RANKL degradation rate | 0.00148 per hour |
Abbreviations: Cmax, maximum denosumab concentration; Tmax, median time to maximum concentration; RANKL, receptor activator of nuclear factor kappa-β ligand; SD, standard deviation; AUC, mean area under the concentration-time curve; ka, first-order absorption rate constant.