TABLE 6

Observed and predicted RSV AUC ratios with RIF as an inhibitor in cynomolgus monkeys and humans

SpeciesAUC Ratio (Observed)90% CI of AUC RatioAUC Ratio (Predicted)
Prediction MethodaImaxIaveIin,max
TotalFreeTotalFreeTotalFree
Cynomolgus Monkey2.891.42–5.31Eq. 133.937.2611.042.9163.0412.79b
Human3.002.51–3.529.512.705.061.8119.724.74b
Cynomolgus Monkey2.891.42–5.31Eq. 23.322.642.901.903.432.97
Human3.002.51–3.522.811.832.371.483.162.32
Cynomolgus Monkey2.891.42–5.31Eq. 33.032.132.411.543.252.51
Human3.002.51–3.522.781.812.341.473.142.29
  • AUC, area under the concentration-time curve; CI, confidence interval; RIF, rifampin; RSV, rosuvastatin.

  • a Fold AUC change predicted using different methods or equations (see Materials and Methods).

  • b Calculated R-value using the approach recommended by US Food and Drug Administration and International Transporter Consortium.