Supplementary Table S2.
Parameter | Formulation, 150 mg | N | Geometric LSM (90% CI) | Ratio of geometric LSM RCD/RCS:HSWG (90% CI) |
---|---|---|---|---|
AUC(0-tlast) (μg·h/L) | HSWG | 14 | 4,516 (3,320, 6,143) | |
RCD | 14 | 4,348 (3,196, 5,915) | 0.96 (0.82, 1.13) | |
RCS | 14 | 4,344 (3,193, 5,909) | 0.96 (0.82, 1.13) | |
AUC(0–48) (μg·h/L) | HSWG | 14 | 4,518 (3,321, 6,148) | |
RCD | 14 | 4,347 (3,195, 5,915) | 0.96 (0.82, 1.13) | |
RCS | 14 | 4,334 (3,185, 5,897) | 0.96 (0.82, 1.13) | |
AUC(0-∞) (μg·h/L) | HSWG | 14 | 4,766 (3,516, 6,462) | |
RCD | 12 | 4,631 (3,402, 6,303) | 0.97 (0.83, 1.13) | |
RCS | 11 | 4,816 (3,531, 6,567) | 1.01 (0.86, 1.19) | |
Cmax (μg/L) | HSWG | 14 | 960 (686, 1,345) | |
RCD | 14 | 735 (525, 1,029) | 0.77 (0.57, 1.03) | |
RCS | 14 | 770 (550, 1,078) | 0.80 (0.60, 1.07) |
For AUC(0-∞), 2 and 3 patients for RCD and RCS, respectively had extrapolated AUCtlast-inf values >20% and could not be included in the analysis.
Abbreviations: AUC = area under the plasma concentration versus time curve; AUC(0-∞) = AUC from zero to infinity; AUC(0–48) = AUC from zero to 48 hours post dose; AUC(0-tlast) = AUC from time zero to time t, where t is the last time point with a measurable concentration; CI = confidence interval; Cmax = maximum plasma drug concentration; LSM = least squares means; N = number of patients; HSWG = high-sheer wet granulation; PK = pharmacokinetic; RCD = roller compaction dry-milled; RCS = roller compaction slurry-milled.