TABLE 6.
D (mg) | K |
N-K |
C max | K |
N-K |
K |
N-K |
AUC | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Route | Cmax(ng/mU | Cmax/D | n | Cmax (ng/ml) | Cmax/D | n | MRa N-K/K | Tmax(min) | n | Tmax(min) | n | AUC (μg·h/L) | AUC/D | F(%) | AUC (μg·h/L) | AUC/D | MR N-K/K |
10 IV | 296 (1.71) | 29.6 | 9 | 2.8 (1.86) | 2.7 | 8 | 0.089 (1.6) | 2 (1) | 9 | 30 (1) | 8 | 113 | 678 | 100 | 22 | 130 | 0.19 |
10 IN | 22.9 (1.97) | 2.3 | 7 | 17.8 (1.89) | 1.8 | 5 | 0.78 | 23 (3.0) | 7 | 79 (1.86) | 5 | 19 | 116 | 17 | n/a | ||
30 IN | 60.8 (1.90) | 2.0 | 10 | 68.1 (1.80) | 2.3 | 10 | 1.12 (1.72) | 14 (3.8) | 10 | 60 (1.76) | 10 | 46 | 91 | 13 | 181 | 361 | 3.95 |
50 IN | 77.6 (2.29) | 1.6 | 10 | 105 (1.63) | 2.1 | 10 | 1.35 (2.37) | 16 (4.4) | 10 | 56 (1.83) | 10 | 64 | 77 | 11 | 291 | 350 | 4.54 |
Abbreviations: μg·h/L, (microgram per hour) per liter; AUC, area under the curve; Cmax, maximum concentration; D, dose; F, bioavailability; ml, milliliter; ng, nanogram; Tmax, time to reach maximum concentration.
Cmax metabolic ratios (MR) were calculated at the individual level, allowing for calculation of geometric mean and standard deviation values by dose level. For the 10-mg IN group, there were only three patients with both ketamine (K) and nor-ketamine (NK) truly informed values, which prompted us to report the ratio of the geometric mean of nor-ketamine over the geometric mean of ketamine. For the 10-mg IV, 30-mg IN, and 50-mg IN groups, the geometric mean of individual level metabolic ratio and ratio of geometric means were near-identical.