Table 1. Pharmacokinetic parameters following a single dose of long-acting i.m. fulvestrant 250 mg in healthy female postmenopausal volunteers (AstraZeneca, data on file) and in postmenopausal women with advanced breast cancer (Trial 0020, Robertson et al, 2003a).
Healthy volunteers | Breast cancer patients (study 0020) | |
---|---|---|
AUC(0–28) (ng ml−1) gmean (CV, %) | 176 (34.5) (n=10) | 148 (45.3) (n=13) |
Cmax (ng ml−1) gmean (CV, %) | 11.4 (44.8) (n=10) | 8.20 (63.8) (n=16) |
tmax (h) median | 144.0 (n=10) | 167.3 (n=15) |
Cmin (ng ml−1) gmean (CV, %) | 2.6 (25.2) (n=10) | 2.62 (33.4) (n=14) |
gmean=geometric mean; SD=standard deviation; CV=coefficient of variation; AUC(0–28)= area under the plasma concentration–time curve from 0 to 28 days; Cmax=maximum plasma concentration; tmax=time to Cmax; Cmin=minimum plasma concentration.