Table 3.

Pharmacokinetic parameter estimates

Cmax, ng/mLAUC, ng h/mL
Placebo
 Mean (SD)10.0 (1.00)<0 (x)
 Median10.0<0
 CV%10.0
400 μg
 Mean (SD)22.8 (9.9)427.1 (276.5)
 Median21.0435.5
 95% CI(−25.5 to 51.1)(−79.6 to 934.0)
800 μg
 Mean (SD)30.75 (8.4)567.5 (243.0)a
 Median30.5648.75
 95% CI(−19.3 to 60.8)(37.6 to 1,100)
1,200 μg
 Mean (SD)63.2 (27.8)a1,077.9 (203.3)a
 Median57.01,055.3
 95% CI(14.9–91.5)(571–1,580)
  • aP < 0.05; determined by comparison of each dose group (400, 800, and 1,200 μg) with placebo group.