Table 1.
Estimated and derived pharmacokinetic parameters of diazepam obtained with the non-compartmental approach
|
Avizafone |
Diazepam |
AIBC |
|
|---|---|---|---|
| Mean (SD) | Mean (SD) | Mean (SD) | |
| AUC0–t (h ng·mL−1) | 5851 (2086) | 5485 (1856) | 5265 (1802) |
| tmax (h)a | 0.75 (0.5–1)b | 1.5 (0.5–96)b | 1 (0.5–2)b |
| Cmax (ng·mL−1) | 231 (60) | 148 (91) | 203 (54) |
| Ke (h−1) | 0.02 (0.013) | 0.017 (0.009) | 0.018 (0.009) |
| t1/2 (h) | 50.1 (35.8) | 54.4 (38.0) | 55.5 (50.8) |
| Relative bioavailabilitya,c | 1.05 (0.85–1.39)b | 1 | 0.95 (0.78–1.23)b |
a
Median.
b
Range.
c
Diazepam is reference treatment.
AIBC, avizafone with atropine–pralidoxime in bi-compartmental auto-injector; AUC, area under the curve; Cmax, maximal concentration; Ke, elimination constant; t1/2, elimination half-life; tmax, time to reach maximal concentration.