Table 4.

Ratio of Geometric Mean AUC_0–48h and E_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 PD (comparisons across renal function groups)
	Factor Xa inhibition
	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 (%)
AUC0–48h	708.5a	593.43	119.4 (75.39–189.07)	27
Emax	46.74a	39.38	118.7 (97.71–144.16)	15
	Moderate RI
	Rivaroxaban 10 mg + erythromycin 500 mg tid	Normal RF Rivaroxaban 10 mg	Geometric mean ratio (%) with 90% CI	Inter-subject CV (%)
AUC0–48h	842.3	593.43	141.9 (97.52–206.59)	27
Emax	53.61	39.38	136.1 (116.13–159.54)	15

	Prothrombin Time
	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 (%)
AUC0–48h	118.7	67.82	175 (115.32–265.42)	31
Emax	9.85	8.24	119.5 (79.73–179.18)	41
	Moderate RI
	Rivaroxaban 10 mg + erythromycin 500 mg tid	Normal RF Rivaroxaban 10 mg	Geometric mean ratio (%) with 90% CI	Inter-subject CV (%)
AUC0–48h	115.1	67.82	169.8 (111.9–257.55)	31
Emax	10.02	8.24	121.6 (81.11–182.28)	41

AUC_0–48h, area under the pharmacodynamic–time curve from time 0 to 48 hours; CI, confidence interval; CV, coefficient of variation; E_max, maximum pharmacodynamic change; PD, pharmacodynamics; RF, renal function; RI, renal impairment; tid, three times daily.

^an = 4.