Table 2.
Area under the curve (AUC) of [14C]midazolam and [14C]1‐hydroxy‐midazolam after administration of a microdose or microtracer [14C]midazolam, presented as median (range)
| Total (n = 15) | Microdose (n = 9) | Microtracer (n = 6) | Mann–Whitney U microdose vs microtracer group (P‐value) | |
|---|---|---|---|---|
| [ 14 C]midazolam | ||||
| AUC0–t (ng L−1 *h) | 46.77 (32.42–196.77) | 46.77 (32.42–196.77) | 48.28 (39.17–81.40) | .86 |
| AUC0–∞ (ng L−1 *h) | 48.90 (34.15–218.80) (n = 14a) | 48.90 (34.15–218.80) (n = 8a) | 49.11 (39.75–82.45) | .66 |
| [ 14 C]1‐hydroxy‐midazolam | ||||
| AUC0–t (ng L−1 *h) | 10.89 (5.28–24.21) | 10.19 (5.28–24.21) | 11.20 (5.84–19.93) | .86 |
| AUC0–∞ (ng L−1 *h) | 12.39 (5.99–26.41) (n = 14a) | 13.14 (7.40–26.41) (n = 8a) | 12.39 (5.99–26.27) | .95 |
| [ 14 C]1‐hydroxy‐midazolam/ [ 14 C]midazolam | ||||
| AUC0–t ratiob | 0.23 (0.11–0.51) | 0.23 (0.11–0.49) | 0.21 (0.13–0.51) | .69 |
a
for 1 subject this parameter could not be established as there were only 2 plasma samples available.
b
AUC0–t ratio = [14C]1‐hydroxy‐midazolam AUC0–t/[14C]midazolam AUC0–t