TABLE 1

Midazolam pharmacokinetic parameters in 18 healthy adults on days 1 (baseline), 7, 9, 13, 20, 27, and 34

Data are expressed as geometric means and LS-GMR with 90% CI.

Parameter (Units)
Day
Geometric Mean
LS-GMR (Day n/Day 1)
90% CI
Cmax (ng/ml) 1 19.7
7 14.9 0.76 0.66-0.87*
9 16.6 0.84 0.73-0.97*
13 20.5 1.04 0.91-1.20
20 20.5 1.04 0.91-1.20
27 21.0 1.07 0.93-1.22
34 22.5 1.14 1.00-1.31*
AUC0-∞ (ng min/ml) 1 2620.4
7 1714.9 0.65 0.59-0.72*
9 1900.6 0.73 0.66-0.80*
13 2210.6 0.84 0.76-0.93*
20 2525.1 0.96 0.87-1.07
27 2699.2 1.03 0.93-1.14
34 2941.1 1.12 1.02-1.24
CL/F (ml/min) 1 2164.2
7 3306.9 1.53 1.38-1.69*
9 2983.8 1.38 1.25-1.52*
13 2565.4 1.19 1.07-1.31*
20 2245.9 1.04 0.94-1.15
27 2101.0 0.97 0.88-1.07
34 1928.2 0.89 0.81-0.99
V/F (1) 1 515.6
7 939.7 1.82 1.57-2.11*
9 663.9 1.29 1.11-1.49*
13 505.6 0.98 0.85-1.14
20 472.0 0.92 0.79-1.06
27 508.3 0.99 0.85-1.14
34 493.9 0.96 0.83-1.11
t1/2 (min) 1 165.1
7 197.0 1.19 1.03-1.38*
9 154.2 0.93 0.81-1.08
13 136.6 0.83 0.72-0.96*
20 145.7 0.88 0.76-1.02*
27 167.7 1.02 0.88-1.18
34
177.6
1.08
0.93-1.24

  • ↵* 90% CI does not satisfy the 0.80-1.25 bioequivalence criteria.