Table 1.
Plasma dronabinol pharmacokinetics for dronabinol oral solution 4.25 mg under fed conditions and dronabinol capsule 5 mg under fed or fasted conditions
| Parameter | Dronabinol oral solution 4.25 mg (fed state)
|
Dronabinol capsule 5 mg (fed state)
|
Dronabinol capsule 5 mg (fasted state)
|
|||
|---|---|---|---|---|---|---|
| Mean (SD) | CV (%) | Mean (SD) | CV (%) | Mean (SD) | CV (%) | |
| Tlag (hour) | 0.15 (0.07)a | 49.30a | 2.02 (1.42)b | 70.19b | 0.52 (0.55)c | 105.17c |
| Tmax (hour) | 7.67 (3.43)a | 44.74a | 5.59 (3.24)b | 57.96b | 1.73 (1.74)c | 100.82c |
| Cmax (ng/mL) | 1.52 (0.97)a | 63.52a | 2.60 (1.74)b | 67.11b | 2.19 (1.06)c | 48.51c |
| AUC0−t (hour × ng/mL) | 9.10 (3.84)a | 42.20a | 10.47 (4.85)b | 46.29b | 4.44 (2.67)c | 60.17c |
| AUC0−∞ (hour × ng/mL) | 10.25 (3.78)d | 36.87d | 12.21 (4.83)e | 39.61e | 4.33 (2.49)f | 57.52f |
| t1/2 (hour) | 9.35 (6.73)d | 71.91d | 10.41 (9.24)e | 88.72e | 4.82 (5.85)f | 121.40f |
Notes:
a
n=52;
b
n=54;
c
n=53;
d
n=30;
e
n=35;
f
n=47.
Abbreviations: AUC0−∞, area under the plasma concentration–time curve from time zero to infinity; AUC0−t, area under the plasma concentration–time curve from time zero to the last measurable concentration; Cmax, maximum plasma concentration; CV, coefficient of variation; SD, standard deviation; t1/2, half-life; Tlag, time to the first measurable concentration; Tmax, time to maximum plasma concentration.