Parameter (Units) Alprazolam 1 mg SL (Test Treatment) N=28 Alprazolam 1 mg IR (Reference Treatment) N=28
AUCinf (ng*hour/mL)
Geometric Mean (%CV) 274.1 (38) 286.3 (31)
Ratio of Adjusted Means (90% CI) 95.75 (91.96, 99.69)
Arithmetic Mean (SD) 289.7 (110.6) 299.1 (92.6)
AUC(0–t) (ng*hour/mL)
Geometric Mean (%CV) 259.5 (33) 271.9 (29)
Ratio of Adjusted Means (90% CI) 95.43 (91.74, 99.27)
Arithmetic Mean (SD) 271.1 (88.1) 282.9 (81.3)
Cmax (ng/mL)
Geometric Mean (%CV) 15.2 (18) 17.2 (19)
Ratio of Adjusted Means (90% CI) 88.27 (83.68, 93.11)
Arithmetic Mean (SD) 15.4 (2.8) 17.5 (3.4)
Tmax (hour)
Median (range) 2.00 (0.500-3.50) 0.892 (0.500-2.50)
t1/2 (hour)
Arithmetic mean (SD) 15.3 (4.6) 15.2 (3.5)
%CV: Percent Coefficients of Variation; IR: Immediate Release; SL: Sublingual; CI: Confidence Interval
Table 1: Summary of pharmacokinetic parameters of plasma alprazolam following single oral doses.
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