Table 4.
Parameter | Formulation, 150 mg | N | Median (min, max) | Median difference RCD/RCS – HSWG (90% CI) |
---|---|---|---|---|
tmax (h) | HSWG | 13 | 1.00 (0.50, 3.00) | |
RCD | 13 | 2.00 (0.50, 3.17) | 0.59 (0.00, 1.25) | |
RCS | 13 | 2.00 (0.50, 3.00) | 0.00 (0.00, 0.75) |
One patient (R77) who showed substantially higher exposures as explained in results was excluded from analysis.
Abbreviations: CI = confidence interval; HSWG = high-sheer wet granulation; max = maximum; min = minimum; N = number of patients; RCD = roller compaction dry-milled; RCS = roller compaction slurry-milled; tmax = time of maximum plasma drug concentration.