Table 6.
Pharmacokinetic summary of decitabine following 3-day treatment and 5-day treatment (pharmacokinetic analysis set)
| Treatment | C max (ng/mL) | T max (h) | AUClast (ng h/mL) | AUC0–∞ (ng h/mL) | T 1/2 (h) |
|---|---|---|---|---|---|
| 3-day treatmenta (n = 6) | |||||
| Mean | 54.44 | 2.43 | 117.84 | 118.93 | 0.58 |
| SD | 20.07 | 0.79 | 50.37 | 50.55 | 0.22 |
| CV% | 36.87 | 32.51 | 42.74 | 42.50 | 38.42 |
| 5-day treatmentb (n = 18) | |||||
| Mean | 222.35 | 0.88 | 179.23 | 180.43 | 0.63 |
| SD | 53.74 | 0.24 | 43.84 | 43.78 | 0.18 |
| CV% | 24.17 | 27.67 | 24.46 | 24.26 | 29.13 |
Pharmacokinetic analysis set included all patients who were randomized and participated in the pharmacokinetic assessments
AUC Area under curve, C max Observed maximum plasma concentration, CV Coefficient of variation, T 1/2 Terminal half-life, T max Time when Cmax was observed
a15 mg/m2 administered over 3 h as an intravenous infusion every 8 h for 3 consecutive days
b20 mg/m2 administered over 1 h as an intravenous infusion once- daily for 5 consecutive days