Pharmacokinetic outcomes: PK study
MR309 200 mg BID dosing was associated with lower geometric mean (CV, %) Cmaxss (4143 [17.2] ng/mL vs 5222 [18.3] ng/mL) and higher Cminss (1915 [29.8] ng/mL vs 1764 [29.9] ng/mL) compared with 400 mg QD dosing (Table 2; Figure 2). Bioavailability comparisons yielded geometric mean ratios (BID/QD dosing) of 79.3% (90% CI 73.5, 85.7%) and 108.5 (90% CI 104.6, 112.6%) for Cmaxss and Cminss, respectively. Correspondingly, less fluctuation was observed with BID dosing (mean 87% [SD 22%]) compared with the QD regimen (145% [49%]; Table 2). The ratio of dose-adjusted AUCtau (BID/QD dosing) indicated broadly equivalent bioavailability across the two dosing schedules (107% [90% CI 103, 111.5]).