Table 3.
Midazolam pharmacokinetics parameter estimates following midazolam 2 mg doses on day 1 and day 16.
| Group A (midazolam + denosumab*) (N = 17†) | Group B (midazolam alone‡) (N = 8) | |||||||
|---|---|---|---|---|---|---|---|---|
| Day | Tmax (h) | Cmax (ng/mL) | AUCinf (ng·h/mL) | t1/2 (h) | Tmax (hr) | Cmax (ng/mL) | AUCinf (ng·h/mL) | t1/2 (h) |
| 1 | 0.5 (0.5–1.0) | 11.6 (5.1) | 35.6 (16.4) | 6.34 (1.83) | 0.5 (0.5–1.0) | 11.3 (5.8) | 31.0 (21.1) | 6.20 (2.01) |
| 16 | 0.5 (0.5–1.0) | 12.0 (4.6) | 36.3 (16.3) | 6.69 (1.67) | 0.5 (0.5–1.0) | 10.9 (3.7) | 29.3 (18.9) | 6.22 (2.83) |
Data are reported as mean (standard deviation) except for Tmax, which is reported as median (range). Note: Study treatment in Group A was midazolam 2 mg orally on day 1 and day 16, and denosumab 60 mg subcutaneously on day 2. AUC, area under the concentration-time curve; Cmax, maximum concentration; t1/2, half-life; Tmax, time of Cmax.
Midazolam 2 mg orally on day 1 and day 16, and denosumab 60 mg subcutaneously on day 2.
Of the 18 subjects who completed study treatment in Group A, 17 were included in pharmacokinetics parameter estimates and 1 was excluded because of prohibited medication use (diltiazem; see text).
Midazolam 2 mg orally on day 1 and day 16.