Table 2.
Summary Statistics of Pharmacokinetic Parameters After Multiple Dose (2 × 10 mg) of NRL‐1
| Pharmacokinetic Parameter | Arithmetic Mean (CV%) | Geometric Mean (CV%) |
|---|---|---|
| Diazepam | ||
| Cmax,0‐4h, ng/mL | 123.0 (73%) | 91.5 (100%) |
| Cmax,4‐8h, ng/mL | 161.4 (77%) | 114.6 (113%) |
| Cmax, ng/mL | 180.2 (68%) | 137.2 (97%) |
| tmax, ha | 5.3 (0.5, 12) | … |
| AUC0‐4h, h•ng/mL | 282 (71%) | 212 (98%) |
| AUC4‐8h, h•ng/mL | 433 (70%) | 327 (97%) |
| AUC0‐t, h•ng/mL | 7297 (58%) | 6067 (73%) |
| AUC0‐∞, h•ng/mL | 7936 (57%) | 6831 (61%) |
| t½, h | 74 (45%) | 67 (50%) |
| CL/F, L/h | 3.4 (59%) | 2.9 (61%) |
| Nordiazepam | ||
| Cmax,0‐4h, ng/mL | 6.6 (71%) | 5.2 (81%) |
| Cmax,4‐8h, ng/mL | 11.7 (78%) | 9.1 (82%) |
| Cmax, ng/mL | 32.1 (55%) | 26.7 (75%) |
| tmax, ha | 144 (24, 240) | … |
| AUC0‐4h, h•ng/mL | 16 (64%) | 13 (68%) |
| AUC4‐8h h•ng/mL | 38 (77%) | 29 (83%) |
| AUC0‐t, h•ng/mL | 5625 (51%) | 4796 (68%) |
| AUC0‐∞, h•ng/mL | 10 840 (23%) | 10 595 (26%) |
| t½, h | 69 (21%) | 67 (22%) |
AUC indicates area under the plasma concentration–time curve; Cmax, peak plasma concentration; CV%, coefficient of variation; tmax, time from dose to Cmax; t½, half‐time of elimination.
a
Values are medians (minimum, maximum). Ranges in subscripts indicate time intervals of measurements.