Pharmacokinetic data summary for the free base of eliglustat tartrate
| Parameter* . | Trough, ng/mL . | Cmean, ng/mL . | Cmax, ng/mL . | AUC(0-τ), ng*h/mL . | Tmax, h . | t1/2, h . | Vz/F, L . |
|---|---|---|---|---|---|---|---|
| N | 22 | 22 | 22 | 22 | 22 | 25 | 26 |
| Mean (SD) | 7.1 (4.3) | 12.9 (6.1) | 21.6 (8.2) | 152.7 (70.1) | 2.3 (0.9) | 6.8 (4.7) | 8650 (4491) |
| Median | 5.7 | 11.9 | 21.7 | 147.4 | 2.0 | 5.1 | 8434 |
| Minimum, maximum | 1.9, 18.5 | 4.4, 25.1 | 7.7, 36.9 | 59.0, 317.0 | 1.0, 6.1 | 3.0, 25.4 | 3880, 21 145 |
| Parameter* . | Trough, ng/mL . | Cmean, ng/mL . | Cmax, ng/mL . | AUC(0-τ), ng*h/mL . | Tmax, h . | t1/2, h . | Vz/F, L . |
|---|---|---|---|---|---|---|---|
| N | 22 | 22 | 22 | 22 | 22 | 25 | 26 |
| Mean (SD) | 7.1 (4.3) | 12.9 (6.1) | 21.6 (8.2) | 152.7 (70.1) | 2.3 (0.9) | 6.8 (4.7) | 8650 (4491) |
| Median | 5.7 | 11.9 | 21.7 | 147.4 | 2.0 | 5.1 | 8434 |
| Minimum, maximum | 1.9, 18.5 | 4.4, 25.1 | 7.7, 36.9 | 59.0, 317.0 | 1.0, 6.1 | 3.0, 25.4 | 3880, 21 145 |
The trough (predose) concentration, maximal observed concentration (Cmax), and time to maximal observed concentration (Tmax) were determined from direct observation of the data. Cmean was derived by exponentiating the mean natural log of each plasma concentration at each patient visit. Area under the curve from time 0 to the last observed concentration, AUC(0-τ), was calculated using the log-linear trapezoidal rule. Values are reported for data pooled across visits during the steady-state period from day 30 to week 52, except for the terminal t1/2 and volume of distribution (Vz/F), which were based on data from single-dose assessments at day 1.