Table 1.
Mean (SD) pharmacokinetic parameters for a nanocrystal dispersion of megestrol acetate (MA-ES) 625 mg/5 mL and a micronized formulation of megestrol acetate oral suspension (MAOS) 800 mg/20 mL administered in a fed or fasting state
| Parameter |
MA-ES 625 mg/5 mL |
MAOS 800 mg/20 mL |
||
|---|---|---|---|---|
| Study 1 (N = 23) | Study 2 (N = 32) | Study 3 (N = 36) | ||
| Fed | Fasting | Fed | Fasting | |
| AUC0–t (ng · h/mL) | 15,287 (4,646) | 11,301 (3,583) | 16,757 (4,670) | 7,011 (4,704) |
| AUC0–∞ (ng · h/mL) | 16,268 (5,174) | 12,095 (4,111) | 18,625 (5,907) | 8,942 (8,934) |
| Cmax (ng/mL) | 1,618 (438) | 1,133 (429) | 1,364 (387) | 187 (107) |
| tmax (h) | 2.91 (1.88) | 1.72 (1.42) | 3.85 (0.89) | 5.89 (6.32) |
| t½ (h) | 39.75 (10.79) | 33.68 (9.02) | 32.84 (9.00) | 31.38 (18.74) |
Abbreviations: AUC, area under the curve; Cmax, maximum plasma concentration; SD, standard deviation; tmax, time to maximum concentration; t1/2, half-life.