3.2.3 Relative Bioavailability Study
Mean plasma emodepside concentration-time profiles are shown in Figure 3
and PK parameters are presented in Table 6. The bioavailability of the
two ASD tablets relative to the reference formulation, emodepside 5 mg
LSF, was lower, with least square mean ratios (test/reference) ranging
from 66% to 80% for AUC0−7d/D and 40% to 77% for
Cmax/D (Table 7). The gastrosoluble tablet was more
bioavailable than the gastroresistant tablet. Bioavailability was lower
in the fed state, and the rate of absorption was slower with the
tablets. The extent of the food effect was similar for the two tablets.
The geometric mean t½ up to 168 hours post-dose was 20
to 25-fold longer than the geometric mean t½ up to 24
hours post-dose.