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. 2013 Jul 20;33(9):665–673. doi: 10.1007/s40261-013-0110-0

Table 4.

Analysis of variance of pharmacokinetic parametersa

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