Table 6.

Bioequivalence analysis of vinflunine blood clearance and of 4-O-deacetyl vinflunine metabolic ratio

	Vinflunine		4-O-deacetyl vinflunine
Group and initial dose level	Geometric mean ± CV of clearance (l h−1 m−2)	Ratio and 90% CI Test : reference	Geometric mean ± CV of metabolic ratio	Ratio and 90% CI Test : reference
Test: Moderate renal impairement (n = 13) 280 mg m−2	20.3 ± 31%	0.88 (0.78, 0.98)*	0.369 ± 31%	1.19 (1.02, 1.38)*
Test: Severe renal impairement (n = 16) 250 mg m−2	16.4 ± 24%	0.72 (0.65, 0.79)**	0.315 ± 34%	1.02 (0.88, 1.17)
Control (n = 118)° 320 mg m−2	23.1 ± 24%	-	0.310 ± 37%	–

*/**Not bioequivalent. ° Sample size for control of 4-O-deacetyl vinflunine metabolic ratio is 44.