TABLE 4.
Summary of main PK parameter of dimdazenil following 2.5 mg multiple-dose administration.
| Parameter | Statistics | 2.5 mg/day (N = 13) |
|---|---|---|
| Cmax,ss (ng/mL) | Mean (SD) | 33.86 (7.88) |
| GM (CV%) | 33.02 (23.7) | |
| AUC0-τ (h*ng/mL) | Mean (SD) | 198.12 (44.67) |
| GM (CV%) | 193.40 (23.4) | |
| AUC0-∞,ss (h*ng/mL) | Mean (SD) | 201.35 (47.57) |
| GM (CV%) | 196.13 (24.4) | |
| AUC0-t,ss (h*ng/mL) | Mean (SD) | 199.62 (47.04) |
| GM (CV%) | 194.49 (24.2) | |
| Tmax (h) | Median (range) | 1.50 (0.5–2.52) |
| t1/2z (h) | Mean (SD) | 3.63 (0.69) |
| Vz (L) | Mean (SD) | 67.40 (10.80) |
| CLz (L/h) | Mean (SD) | 13.25 (3.13) |
| Ra (AUC) | Mean (SD) | 1.05 (0.09) |
| GM (CV%) | 1.05 (8.4) | |
| Ra (Cmax) | Mean (SD) | 1.13 (0.19) |
| GM (CV%) | 1.11 (17.8) |
Data are expressed as arithmetic mean with standard deviation (SD) and geometric mean (GM) with coefficient of variation (CV), except for Tmax which is expressed as median (range).
Cmax,ss: maximum observed concentration in steady-state; AUC: area under the concentration–time curve; AUC0-τ: AUC, during the dosing interval; AUC0-∞,ss: AUC, from time of administration to the last measurable concentration in steady-state; AUC0-t,ss: AUC, from time of administration to the last measurable concentration in steady-state; Tmax: time to reach the maximum observed concentration; t1/2z: apparent terminal elimination half-life; CLz: apparent clearance; Vz: apparent volume of distribution; Ra(Cmax): accumulation ratio based on Cmax, the formula is Cmax,ss in multiple dose/Cmax in single dose; Ra (AUC): accumulation ratio based on AUC0-τ, the formula is AUC0-τ in multiple dose/AUC0-t in single dose.