Table 2.
Parameter | Visit | n a | Adjusted geometric mean | Comparison (day/baseline) | Geometric mean ratio | 90% CI for ratio |
---|---|---|---|---|---|---|
AUC0–12 h (hour·ng/mL) | Baseline | 22 | 71.84 | |||
Day 8 | 22 | 69.90 | Day 8 vs. baseline | 0.97 | 0.87−1.09 | |
Day 36 | 21 | 67.11 | Day 36 vs. baseline | 0.93 | 0.83−1.05 | |
AUCinf (hour·ng/mL) | Baseline | 22 | 82.17 | |||
Day 8 | 21 | 81.70 | Day 8 vs. baseline | 0.99 | 0.88−1.12 | |
Day 36 | 20 | 79.35 | Day 36 vs. baseline | 0.97 | 0.85−1.09 | |
Cmax (ng/mL) | Baseline | 22 | 24.81 | |||
Day 8 | 22 | 27.13 | Day 8 vs. baseline | 1.09 | 0.94−1.28 | |
Day 36 | 21 | 23.26 | Day 36 vs. baseline | 0.94 | 0.80−1.10 |
AUC0–12 h, 0–12‐hour area under the concentration‐time curve; AUCinf, area under the concentration‐time curve to infinity; CI, confidence interval; Cmax, peak plasma concentration; PK, pharmacokinetic.
n = number of patients with nonmissing values. The log transformed primary PK parameters of Cmax, AUC0–12 h, and AUCinf were analyzed using a mixed effect model with day as fixed and patients as random effect. Midazolam 5 mg was administered on baseline (reference), day 8 (test), and day 36 (test).