Table 3.

Ratio of Geometric Mean AUC_∞ and C_max Data and Associated 90% Confidence Interval After the Administration of Rivaroxaban 10 mg with and without Erythromycin 500 mg tid in Participants with Normal and Impaired Renal Function (n = 8 per Test and Reference Groups)

	Assessing the effects of renal function and concomitant erythromycin on rivaroxaban PK (comparisons across renal function groups)
	Test	Reference
	Mild RI
	Rivaroxaban 10 mg + erythromycin 500 mg tid	Normal RF Rivaroxaban 10 mg	Geometric mean ratio (%) with 90% CI	Inter-subject CV (%)
AUC∞, ng · h/mL	3,078.7	1,745.5	176.4 (136.59–227.77)	27
Cmax, ng/mL	277.2	178.17	155.6 (118.03–205.07)	29
	Moderate RI
	Rivaroxaban 10 mg + erythromycin 500 mg tid	Normal RF Rivaroxaban 10 mg	Geometric mean ratio (%) with 90% CI	Inter-subject CV (%)
AUC∞, ng · h/mL	3,475.5a	1,745.5	199.1 (152.81–259.44)	27
Cmax, ng/mL	292.42	178.17	164.1 (124.51–216.33)	29

	Assessing the effects of concomitant erythromycin on rivaroxaban PK (comparisons within renal function groups)
	Test	Reference
	Mild RI	Mild RI
	Rivaroxaban 10 mg + erythromycin 500 mg tid	Rivaroxaban 10 mg	Geometric mean ratio (%) with 90% CI	Intra-subject CV (%)
AUC∞, ng · h/mL	3,078.7	2,001.11	153.9 (137.27–172.43)	14
Cmax, ng/mL	277.2	219.27	126.4 (110.59–144.51)	16
	Moderate RI Rivaroxaban 10 mg + erythromycin 500 mg tid	Moderate RI Rivaroxaban 10 mg	Geometric mean ratio (%) with 90% CI	Intra-subject CV (%)
AUC∞, ng · h/mL	3,475.5a	2,035.57	170.7 (151.14–192.88)	14
Cmax, ng/mL	292.42	242.26	120.7 (105.59–137.98)	16

AUC_∞, area under the plasma concentration–time curve from time 0 to infinity; CI, confidence interval; C_max, maximum plasma concentration; CV, coefficient of variation; h, hour; PK, pharmacokinetics; RF, renal function; RI, renal impairment; tid, three times daily.

^an = 7.