described in their entirety. All randomized subjects who received at least 1 dose of study drug were included in the safety analyses. Summary statistics were calculated for all pharmacokinetic parameters by dose or food condition. The geometric mean ratio (GMR) (fed/fasting) of C max and AUC and the 90% CI for the GMR were calculated to evaluate the effect of food on the pharmacokinetic parameters of mirabegron.
In studies 2, 3, 4, and 5, the GMR of the C max and AUC for male versus female subjects (with 90% CIs) were estimated to evaluate the effect of sex on pharmacokinetic parameters.
In studies 4 and 5, the GMR of mirabegron C max and AUC 0-τ on the last day versus C max and AUC 0-24 on the first day (with 90% CIs) were estimated to assess accumulation of mirabegron with multiple dosing.