Table 7.
Comparison of the pharmacokinetic parameters between female and male subjects for the levetiracetam 3DP fast melt and levetiracetam conventional tablet under fasting conditions
| Parameter | Female subjects | Male subjects | ||||||
|---|---|---|---|---|---|---|---|---|
| Levetiracetam 3DP fast melt Fasted N = 14 |
Conventional tablet Fasted N = 14 |
Levetiracetam 3DP fast melt Fasted N = 18 |
Conventional tablet Fasted N = 18 |
|||||
| Meana | (c.v.%) | Meana | (c.v.%) | Meana | (c.v.%) | Meana | (c.v.%) | |
| T max (h) | 1.00 | (68.5) | 0.67 | (75.3) | 0.50 | (62.4) | 0.50 | (57.2) |
| C max (µg/mL) | 38.190 | (22.4) | 34.475 | (13.6) | 29.448 | (32.5) | 27.372 | (16.7) |
| AUC0–T (µg·h/mL) | 323.946 | (17.0) | 304.702 | (17.0) | 252.379 | (13.6) | 251.780 | (13.9) |
| AUC0–∞ (µg·h/mL) | 331.870 | (17.8) | 312.097 | (17.3) | 262.639 | (13.9) | 262.679 | (14.4) |
| T half (h) | 6.47 | (12.2) | 6.34 | (15.0) | 7.641 | (9.6) | 7.77 | (11.7) |
T max time to maximum observed plasma concentration, C max maximum observed plasma concentration, AUC 0–T area under the plasma concentration–time curve from time zero to the time of the last measurable concentration, AUC 0–∞ area under the plasma concentration–time curve from time zero to infinity, T half terminal elimination half-life, c.v. coefficient of variation, 3DP three-dimensional printing
aMedian for T max