Table 6.
Pharmacokinetic Parameters of Ibuprofenamine in the MAD Study
| Parameter | Ibuprofenamine Dose (Twice a Day for 7 Days) | |
|---|---|---|
| 70mg(n=8) | 140mg(n=7) | |
| Day 1 | ||
| Tmax (h) | 16.63 (9.00, 24.00) | 16.14 (9.00, 24.00) |
| Cmax (pg/mL) | 41.49 (37.0%) | 68.19 (56.7%) |
| AUClast (h·pg/mL) | 1255.13 (28.1%) | 2231.46 (42.8%) |
| Day12 | ||
| Tmax,ss (h) | 9.25 (1.00, 24.00) | 12.14 (0.00, 40.00) |
| Css_max (pg/mL) | 518.22 (65.8%) | 2560.17 (91.4%) |
| Css_min (pg/mL) | 78.66 (76.1%) | 674.09 (39.0%) |
| AUCss (h·pg/mL) | 2702.24 (38.1%) | 13,617.58 (59.6%) |
| Rac (Cmax) | 3.86 (0.77, 11.83) | 13.82 (0.93, 21.24) |
| Rac (AUClast) | NC | 11.08 (8.60, 14.46) |
Note: Data are shown as geometric mean (Coefficient of variation %), except Tmax which is as median (min–max) and Rac which is as geometric mean (90% confidence interval).
Abbreviations: MAD, multiple ascending dose; Cmax, maximum plasma concentration; Tmax, time to achieve Cmax; AUClast, area under the concentration–time curve (AUC) from time zero to the last quantifiable concentration; Cmax,ss, maximum plasma concentration at steady state; Cmin,ss, minimum plasma concentration at steady state; Tmax,ss, time to achieve Cmax,ss; AUCss, AUC over the dosing interval at steady state; Rac(Cmax), observed accumulation by Cmax; Rac (AUClast), observed accumulation by AUC; NC, not calculated.