TABLE 3

Compositions of mirabegron and its metabolites in urine and plasma after a single oral administration of 160 mg of [¹⁴C]mirabegron to four healthy male subjects

Components are listed in the order of elution.

Metabolites	% of Dose in Urine at 0–48 h^{^a}	% Profiled Radioactivity in Plasma^{^b}
Metabolites	% of Dose in Urine at 0–48 h^{^a}	2 h	4 h	8 h	12 h
Unidentified	1.1 ± 0.2	2.4	1.7	1.8	3.1
M9	0.6 ± 0.1	N.D.	N.D.	N.D.	N.D.
M8	1.3 ± 0.3	2.2	1.4	N.D.	N.D.
M17	2.0 ± 0.6	N.D.	N.D.	N.D.	N.D.
M12, M13 (and M14^{^c})	1.4 ± 0.3	14.0	15.0	13.8	13.4
M11 (and M14^{^c})	3.2 ± 0.6	13.3	14.2	13.8	11.2
M15	0.6 ± 0.1	6.9	5.9	3.5	N.D.
M16	1.7 ± 0.5	3.3	4.3	6.2	7.6
M5	2.9 ± 0.8	3.7	4.9	9.4	13.0
Mirabegron	18.4 ± 1.6	46.4	30.9	28.6	31.0
Others	9.7 ± 0.9	7.8	21.7	22.9	20.7
Total	43.0 ± 3.3	100	100	100	100

N.D., not detected (below the detection limit).
↵a Values are mean ± S.D.; n = 4.
↵b Values were obtained using pooled samples of four subjects.
↵c Metabolite M14 was found as the structural isomer of metabolite M11 between the mixture peak of M12/M13 and the M11 peak.