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. 2019 Aug 3;106(6):1380–1388. doi: 10.1002/cpt.1558

Table 2.

Geometric mean ratio (midazolam and secukinumab/midazolam) and 90% CIs for PK parameters (PK analysis set)

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.

a

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).