Table 5

Central value estimates of pharmacokinetic parameter by sex

Central value estimatesa
ParameterMalesFemalesP
Day 1
 Tmaxb (h)0.91.00.412
 Cmaxc (ng/ml/mg)880.120d
 AUCc (h·ng/ml/mg)68580.067d
Day 28
 Tmax (h)0.81.00.651
 Cmaxc (ng/ml/mg)7110.205d
 AUC0–24c (h·ng/ml/mg)46650.233d
 Cminc (ng/ml/mg)0.81.30.110d
  • a Adjusted means (least-squares means) after adjusting for dose level and body weight in analysis of covariance for Tmax and antilogarithms of adjusted means in logarithms for others.

  • b Tmax, time to maximum observed concentration; Cmax, maximum observed plasma concentration; AUC, area under the plasma concentration-time curve from time 0 to infinite time; AUC0–24, area under the plasma concentration-time curve over a dosing interval on Day 28.

  • c Dose-normalized.

  • d Data analyzed on transformed log scale.