Table 4.
Group | PK parameter | Geometric LS means | Geometric mean ratiob | 90 % CIc | |
---|---|---|---|---|---|
Test group | Reference (group 1: healthy) | ||||
2: Mild | AUC∞ | 958.8 | 703.3 | 1.36 | 0.94–1.97 |
AUClast | 937.0 | 698.6 | 1.34 | 0.93–1.94 | |
Cmax | 167.0 | 134.6 | 1.24 | 0.89–1.72 | |
t max d | 1.50 | 1.50 | 0.00 | ||
3: Moderate | AUC∞ | 1,363.9 | 703.3 | 1.94 | 1.34–2.81 |
AUClast | 1,358.0 | 698.6 | 1.94 | 1.35–2.81 | |
Cmax | 269.7 | 134.6 | 2.00 | 1.45–2.78 | |
tmax d | 2.25 | 1.50 | 0.75 | ||
4: Severe | AUC∞ | 1,513.9 | 703.3 | 2.15 | 1.49–3.12 |
AUClast | 1,472.3 | 698.6 | 2.11 | 1.46–3.04 | |
Cmax | 214.0 | 134.6 | 1.59 | 1.15–2.20 | |
tmax d | 1.50 | 1.50 | 0.00 |
aGroups categorized according to degree of renal impairment
bRatio of geometric means of test and control groups
cA 90 % CI that falls within the interval 0.8–1.25 leads to the conclusion that the two groups are bioequivalent
dThe median values in the first two columns and the difference of median values in the column of geometric mean ratio are presented, respectively
AUC, area under plasma concentration–time curve; AUClast, AUC from time zero to time of last measurable plasma concentration; AUC∞, AUC from time zero to infinity; Cmax, maximum plasma concentration; LS, least squares; PK, pharmacokinetic; tmax, time to reach Cmax