TABLE 1

Summary of pharmacokinetic parameters and statistical tests (mean ± S.D.)

ParametersPre-ExposurePostexposureP ValueEquivalency Test
Geometric Mean Ratio (90% CI)
CAF AUC0–12h (mcg/ml × h)35.1 ± 11.935.3 ± 13.00.8780.99 (0.93, 1.05)
CAF Cmax (mcg/ml)4.80 ± 1.224.93 ± 1.160.6141.04 (0.93, 1.17)
MDZ AUCinf (ng/ml × h)97.9 ± 43.598.6 ± 37.90.8931.03 (0.93, 1.13)
MDZ Cmax (ng/ml)33.2 ± 12.731.6 ± 14.40.7030.93 (0.69, 1.24)
TOL AUCinf (mcg/ml × h)745 ± 177815 ± 2510.1971.07 (0.95, 1.20)
TOL Cmax (mcg/ml)54.5 ± 5.963.6 ± 15.40.0741.15 (1.01, 1.30)
DEX AUC0–12h (ng/ml × h)9.41 ± 6.9610.3 ± 8.50.3371.04 (0.91, 1.20)
DEX Cmax (ng/ml)1.37 ± 1.021.05 ± 0.350.7661.02 (0.86, 1.20)
  • AUC0–12h, area under time-concentration curve analyzed from time 0 hour to 12 hours; AUCinf, area under time-concentration curve analyzed from time 0 hour to infinity.